Posts Tagged medical device

JOBS: May, 2019


Please see some of my current opportunities below. All opportunities are for local candidates with valid work visa and require deep industry experience.  If you have an interest then please send an email (resume as an attachment) at wd underscore darshana at hot mail dot com.

Job Search Human Resources Recruitment Career ConceptRegulatory Manager – San Jose, CA
Requires 8+ years of experience in pharma, ideally experience in biologics.

Clinical Trial Manager – San Jose, CA
Ideal experience: 8+ years experience in medical devices, ideal in neuromodulation,  running clinical trials, working with clinicians and medical centers.

Clinical Trial Manager – San Jose, CA
Ideal experience – 8+ years of hands on experience in running pharma trials at manager level. Running clinical studies in biologics is a major plus.

Manufacturing Engineer – San Jose, CA
Requires 8+ years of experience in medical device manufacturing.

Director of Manufacturing Automation – San Jose, CA

This position requires a dynamic, energetic, self-driven, engineering leader with broad manufacturing engineering and automation experience & will report to VP of Manufacturing Operations. The Director of Manufacturing Automation will lead the development of fully automated manufacturing systems for all aspects of company’s disposable drug tablet manufacturing. This individual will be responsible for defining system requirements, developing proof of principle systems, developing timelines and managing budgets and providing direct oversight and management of automation suppliers as well as driving the implementation and validation of manufacturing lines. This individual will work closely with product development, manufacturing engineering and quality in order to ensure manufacturability, achievement of targets, and develop processes for optimum manufacturability.

Responsibilities: Define functional & detailed requirements & specifications for manu automation, including quality & regulatory requirements; Manage internal & external process automation programs, project schedules & budgets; Develop facility plans & specifications for manufacturing scale-up; Oversee installation & qualification of automated manu systems; Comply with USFDA cGMP regulations, (ISO), Company policies, operating procedures, processes & task assignments.

Requirements: Experience managing and leading complex cross functional projects involving, electrical, mechanical, quality aspects; Experience with mechatronics or automation engineering including machine, mechanism and fixture design; Strong problem solving and analytical skills; experience with use of statistical analysis & design of experiments for product optimization & validation activities; Experience with lean manufacturing, design for manufacturing, design for test & test implementation. This position requires interface throughout all levels and functions of the organization; requires a cooperative team-balanced perspective for appropriate output and task outcome.  BS/MS in Mechanical, Electrical or Industrial Engineering & 15+ years’ experience managing an engineering group responsible for medical device development and manufacturing engineering with a strong history of hands-on experience is required. Also required Deep expertise in manufacturing automation for large scale manufacturing.

Director of Pilot Manufacturing – San Jose, CA

Innovative medical device company located in San Jose, CA has an immediate opening for Director of Pilot Manufacturing.  This position will report to VP of Manufacturing Operations. This low volume production line is crucial to the company’s several ongoing preclinical studies.

Duties and Responsibilities
Lead day to day operations including injection molding, aseptic processing, capsule assembly, supply chain and other related activities; Develop detailed production planning, resource allocation, equipment maintenance, operator training etc.; work closely with product development, pre-clinical & clinical groups and quality in order to ensure achievement of targets & develop manufacturing plans & detailed production schedules; Manage inventory of raw materials & injection molded components; Manage human resources in pilot manufacturing; Maintain a strong commitment to quality; Comply with U.S. Food and Drug Administration (FDA) cGMP regulations, other regulatory requirements (ISO), Company policies, operating procedures, processes, and task assignments.

Requirements
Strong problem solving & analytical skills; Experience with use of statistical analysis & design of experiments for product optimization and validation activities; Experience with lean manufacturing, design for manufacturing, design for test & test implementation; Experience working with ERP systems & Broad GMP manufacturing background with Class III medical devices. Requires BS/MS in Mechanical, Electrical or Industrial Engineering and 15+ years’ experience managing & supervising manufacturing with a strong history of hands-on experience successfully transferring new products into manufacturing & Deep technical experience with manufacturing processes, design control and quality systems. Also required, strong problem solving and analytical skills; Experience with use of statistical analysis and design of experiments for product optimization & validation activities; Experience with lean manufacturing, design for manufacturing, design for test and test implementation; Experience working with ERP systems. Also essential is proven ability to coach & develop employees & develop effective cross functional relationships. This position requires interface throughout all levels & functions of the organization.

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JOBS – June, 2016


All US based opportunities require valid US work visa and prior experience in biomedical industry.  Most of my current needs are in engineering and all engineering opportunities require medical device experience.  I have added some other opportunities in science, sales, BD etc.

I will be adding more opportunities.  If interested in any opportunities below, please send me an email (resume as an attachment) at wd_darshana at hot mail dot com and include position title in the subject line.  Please include in the email, how well the description matches your background and where the gaps are, if any.  All leads or referrals are greatly appreciated.

Director of Engineering – San Jose, CA
(Medical device implantable experience and hands-on engineering passion required).

Automatic Test Equipment Engineer – San Jose, CA
Immediately available.  Requires medical device experience. Send in resume ASAP.

Manufacturing Quality Engineer – San Jose, CA
Immediately available. Please send in resume ASAP.

Biochemist – San Jose, CA
Requires MS with 6+ years experience or PhD with 3 years experience in Biochem, Molecular Biology or related.  Immediately available, send in resume ASAP, if interested.

Quality Assurance Manager – San Jose, CA


Senior Manufacturing Engineer – San Jose, CA


Manufacturing Technician – San Jose, CA


Senior Mechanical Engineer – San Jose, CA

Biologist – San Jose, CA
Software Sales – San Jose, CA
Seed stage company offering a suite of subscription based software products, supported by cloud infrastructure, has an exciting opportunity for software sales professional, to join as member of the core founding team.  Although at pre-funding stage, the company is already generating revenues, with massive and growing database of products that can help scientists make environmentally friendly decisions throughout product development life-cycle.  Extensive customer relationship experience is required.  Familiarity with SciFinder, Reaxys etc. is required.   

Engineering Technician – Mt. Laurel, NJ

An innovative medical device company focused on treatment of cardiac diseases, has an exciting opening for Engineering Technician, in Mount Laurel, New Jersey.

Requirements: BS in EE, 3+ years experience as R&D Electrical Engineering Tech/ Testing Engineer, Prior experience in strongly regulated industries (e.g. medical, defense etc.), Prior experience with reliability tests and assembly.

Job functions:
* Conduct all assigned tests, under the direction of a senior engineer.
* Implement reliability test programs and test setups to implement test protocols.
* Conduct and document test protocols in component and system reliability, failure analysis, etc.
* Ensure compliance with regulations including QSR, ISO Standards and corporate policies.
* Specify and purchase components for test setups and prototypes.
* Procure and maintain engineering lab equipment in accordance with quality practices.

Senior Business Development Role – EU

Reporting To: Head – Global BD to manage all aspects of business development across the CRO portfolio of services; secure and retain business through professional, consultative & proactive sales activities directed at key decision makers.

Responsibilities:
Maintain knowledge of all appropriate cross-sell opportunities; Continued awareness of competitive activities, positioning & pricing; Work with regional & international counterparts to develop & close integrated opportunities; Analyze potential opportunities & develop sales plans for each target account; Develop in-depth knowledge of customer organization; Represent company at various industry conferences & trade shows; Prepare & lead sales presentation; Educate team in customer culture, operational needs/methods & sales techniques; Handle follow-up related to sale & drive completion of contract;  Maintain high visibility in customer organization; Monitor customer satisfaction; Record, plan & coordinate customer sales activities in CRM (SALESFORCE) system.

Requirements:  BS or MS in Life Sciences – PhD. preferred; 10+ yrs experience in BD / sales for CRO, CMO or related in life sciences; Ideally industry experience in combination of pharma or biotech in discovery research, CMC or commercial manufacturing technical roles; Solid understanding of drug discovery & development process; Track record of achievement in terms of sales goals; Experience working with international clients & colleagues; Ability to visualize & integrate company’s service portfolio across the drug development continuum;  Ability to cross-sell & credibly represent company services to clients; Ability to work from home-based office

Additional details: The position is located in EU.  Base pay: between 100,000 to 125,000 euros, car: 800 euros per month, VPP: 5% of base pay; Pension benefits: as applicable per country, Designation – Regional Director, BD

Analog Design & Embedded Systems Engineering Leader – San Jose, CA

Innovative, well funded bio-medical startup with disruptive technology has an exciting opportunity for analog design engineering leader, in San Jose, CA. Stock options, in addition to working on something truly exciting and life changing, would be a huge upside in this opportunity.  Requirements include, years of steady experience and passion for engineering problem solving, natural ability to take leadership role (MBA not required). This opportunity is immediately available and if you are engineering problem solver then it is one of the most exciting opportunities you may come across.  

Leads Engineer – Austin, TX or San Jose, CA

Requires BS in mechanical engineering, related to biomedical engineering and 10+ years medical device experience.  Highly desired, experience designing and developing medical products with implantable leads like cardiac pacemaker leads, proficiency in CAD, SolidWorks, and experience with MatLab, hands-on experience for fabricating prototype leads and related fixtures and tooling.

Responsibilities:   

  • Design and develop new conceptual leads in groundbreaking fields of medical devices.
  • Prototype lead designs and perform preliminary bench top testing
  • Develop processes for advanced lead designs
  • Develop, document, and implement test protocols for design verification and process validations
  • Design tooling for manufacture and assembly of implantable leads
  • Support in vivo and clinical evaluation of developed components

 

EMBEDDED SOFTWARE/FIRMWARE ENGINEER FOR MEDICAL DEVICES – Austin, TX or San Jose, CA

Requires: BS in Electrical or Software Engineering & 5+ years exp designing & developing embedded systems for medical devices; expertise in embedded C/C++, in optimization for performance & memory usage; exp developing apps that run a variety of OS/RTOS targets; working in structured environment w/ source control & bug tracking systems; exp developing low level device drivers for SPI, I2C, USB, LCD, ADC, DAC, exp with variety of CPU architectures (Arm Cortex M3/M4, TI MSP430 etc.; exp w/ board bring-up; effective use of hardware test equipment including logic analyzers, digital storage oscilloscopes, etc. Requires proficiency with Microsoft Office tools.

Responsibilities:
* Develop firmware for very low-power, battery powered systems consisting of a mix of analog, digital & RF circuitry in highly integrated, low power embedded designs
* Participate in design activities at architectural & implementation levels
* Design & implement error checking & fault handling, robustness & safety features
* Document software design & implementation
* Support V&V testing, work with V&V team to develop test plans & protocols
* Adhere to standards to help ensure compliance with FDA, ISO, AAMI & UL standards.

Director, Quality Assurance – Mt. Laurel, NJ
In the process of getting filled. 

 

Requirements include: Bachelors degree; 10-12 years experience in QA including medical device industry experience and supervisory/ management experience; & Good working knowledge of domestic & international requirements & regulations such as FDA, ISO, GMP etc.

Tasks:
* Work with contract manufacturer to ensure that devices are manufactured in compliance with US and international quality system requirements.
* Participate in product development teams on behalf of Quality Systems. Identify and resolve quality issues throughout product development process to assure successful audits and regulatory filings.
* Review all product complaints and ensure timely reporting of those events to domestic and international regulatory agencies as necessary.
* Schedule, conduct and assist in responding to internal audits , supplier audits and inspections.
* Maintain a functional CAPA system in compliance with applicable regulations
* Maintain ISO 13485:2003 facility registration in accordance with applicable standards.
* Provide guidance and supervision for Shipping/Receiving Clerk as it relates to completion of receiving inspections and other quality related functions.
* Ensure that the Quality Systems function is carried out in accordance with GMP and ISO directives.
* Review and revise quality system documentation to ensure compliance with domestic and international quality and regulatory requirements.
* Manage, supervise and train staff, oversee projects ongoing within departments, carry out departmental administrative duties.
* Schedule and complete timely management review presentations.
* Manage the document services function to ensure that quality systems documents, records and regulatory submissions are controlled.
* Manage product release and non-conforming product activities
* Maintain program to ensure adequate training of personnel on quality system documentation. Work with HR Department on companywide training activities.
* Ensure employees training on the Quality Systems Regulation and key international regulations and standards.
* Manage the program for handling product returns, returned product evaluations (and repair/rework, where applicable), complaints and customer feedback in accordance with internal policies and procedures.

Senior Clinical Research Monitor: Located anywhere (requires 80% travel)

Position Summary: Responsible for data quality & regulatory compliance at US clinical trial investigational sites. This responsibility is carried out by conducting on-site monitoring visits with Investigator & other research personnel.  Highly competitive salary.

Primary Responsibilities
* Orient site personnel to study protocol/procedures
* Monitor compliance to FDA Regulations & study protocol
* Monitor & promote compliance to local IRB reporting regulations
* Manage study site activities through frequent on-site visits
* Perform initial, interim & closeout study visits
* Communicate findings to investigators & study staff at the site
* Prompt reporting of compliance issues to in-house staff
* Follow-up on all outstanding issues to ensure each matter is addressed in a timely fashion
* Provide timely communication & written reports to the Clinical Affairs department after each monitoring visit

Additional Responsibilities
* Schedule on-site monitoring activities & travel in conjunction with company travel policies.
* May be required to supervise additional field monitors
* Up to 80% travel required.

Education and Experience Requirements
* This position requires a RN, BS, or similar degree (CRCC) with at least 5 years experience in monitoring clinical studies. The candidate must be very familiar with all FDA regulations governing IDE clinical trials.
* Experience in cardiac medical device related clinical trials
* Experience in clinical trial data management

Field Clinical Engineer (FCE) – Germany ( several locations: North Bavaria and Thüringen)

Requirements: BS in Engineering, Science or related; 5+years experience with use of invasive cardiovascular medical devices; knowledge of device-based cardiac rhythm & heart failure management; Prior experience working with clinical studies; Ability to quickly analyze & resolve clinical/technical issues; Frequent traveling to investigational sites, corporate offices, investigator meetings &  industry meetings.

Tasks:
* Develop a strong rapport with clinical sites by acting as consultants to support the site’s needs.
* Responsible for supporting all field-based activities at clinical sites.
* Drive enrollment by ensuring that investigational sites receive the necessary support in order to enroll, implant, and follow patients in a manner consistent with the clinical protocol.
* Support implant procedures and follow-ups at clinical sites
* Share clinical / technical experiences with other personnel in order to improve understanding of product behavior, improve product performance and product acceptance by customer.
* Communicate activities and issues at clinical sites with other company personnel
* Fulfill all administrative requirements including the collection of relevant technical data and completion of necessary documentation

Senior Electrical Engineer – Mt. Laurel, NJ – may be filled soon

An innovative medical device company focused on treatment of cardiac diseases, has an exciting opening for Senior Electrical Engineer in Mount Laurel, New Jersey.

Requirements: B.S. in EE; 5+ years experience as R&D EE in regulated industries (i.e Medical, defense, etc.); Applications development & PM experience; exp writing protocols, reports, regulatory documents; Understanding of patent applications & processes.  Exp in circuit design (Analog & mixed-mode circuits) & with digital signal processing algorithms, a big plus.

Tasks:
* Provide project leadership in product design & specifications, under direction of VP Product Development.
* Develop reliability tests programs &  setups to implement test protocols
* Work closely with vendors (i.e design subcontractors) on product requirements & specifications.
* Conduct design reviews & ensure compliance of design regulations including QSR, ISO standards and corporate policies.

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JOBS – November, 2015


Please see below some of my immediate opportunities. All opportunities are for candidates located in the United States only.  When sending your resume, please include details on your current compensation and compensation expectations.  Also, include in the email a short summary of your background and your key strengths. Please send resumes to wd_darshana at hot mail dot com.

Research Associate/ Scientist – San Jose, CA
Innovative, well funded startup with novel drug-delivery technology has an immediate opening for research associate, in San Jose, CA.  
Requirements include, solid track record in bioanalytical assays.  Proficiency in HPLC, Elisa immunoassays, luminescence assays, fluorescence assays or related is required.  Experience in quantitative analysis, variability analysis in tissue and plasma, experience in pharmacokinetics, and experience in biologics a big plus.  Stocks and benefits make this a highly attractive opportunity to be involved in cutting edge technology, at grounds level.  

CLS Lab Manager – Santa Clara, CA

Minimum Qualifications:
The lab manager must possess an active, valid license issued by the State to perform high complexity testing pursuant to chapter 3 of Business and Professions Code or to practice medicine, osteopathy or podiatry pursuant to chapter 5 of Business and Professions Code appropriate to the specialty or specialties they are supervising; and– appropriate to the specialty or specialties for which they are consulting and, for the specialties of diagnostic immunology, chemistry, hematology, and microbiology, must–
(1) Have earned a bachelor’s degree in a chemical, physical or biological science or medical technology from an accredited institution; (CLS required)
(2) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty or subspecialty in which they supervise.

Duties and Responsibilities:
The lab manger shall be accessible to testing personnel at all times testing is performed by providing on-site, telephone or electronic consultation to resolve technical problems in accordance with policies and procedures established either by the laboratory director.
The lab manager shall be responsible for ensuring that tests and examinations are performed in compliance with chapter 3 of the Business and Professions Code and Title 42, Code of Federal Regulations, Part 493 standards as published October 1, 1994, regarding clinical laboratories and–
(1) Be responsible for providing day-to-day supervision of high complexity test performance by a testing personnel;
(2) Be responsible for monitoring test analyses and specimen examinations to ensure that acceptable levels of analytic performance are maintained.
(3) Assure that all remedial actions are taken whenever test systems deviate from the laboratory’s established performance specifications;
(4) Ensure that patient test results are not reported until all corrective actions have been taken and the test system is properly functioning;
(5) Provide orientation to all testing personnel;
(6) Ensure proper training and competency assessment of all supervised laboratory personnel;
(7) Ensure that Proficiency Testing procedures are followed as specified in Proficiency Testing Procedure;
(8) Timely review of all data and programs specified in the Quality Assessment Procedure as authorized

Project Manager with strong hands-on engineering plus bio background – Milpitas, CA

This is an exciting opportunity with a huge potential upside in stocks in a very innovative company with unique drug delivery technology.  
Strong technical background plus background in pharma chemistry and 10+ years experience with microsoft projects is ideal.  Drug-delivery device experience, a big plus.   

Director of Quality Engineering – Milpitas, CA

There is an immediate opportunity for Director of Quality Engineering.  It requires 10+ years experience in implantable device.  Some pharma experience highly desired.  Experience in implementing QE systems, a great plus.  This is very exciting opportunity to be involved in multiple projects with huge upside, in stocks potential.  Requires engineering background.

Director of Manufacturing Engineering – Milpitas, CA

There is immediate opening for Director of Manufacturing, that requires 10+ years experience in implantable devices.  Experience with injectible drugs, pills highly desired.  Strong hands-on expertise in tooling is required.  This is very exciting opportunity to be involved in multiple projects with huge upside, in stocks potential (a once in a lifetime kind of an opportunity).  

Post-doc opportunity – San Jose, CA

There are opportunities for some excellent post-docs for a drug delivery company.  These opportunities are for candidates with recent Ph.D. in Biochemistry or related and interest in obtaining exciting industrial post doc opportunity with exciting startup.

Senior Biochem Scientist- San Jose, CA

More details will be posted soon.  Meanwhile, candidates with strong drug delivery experience, please contact me.

Senior Quality Engineer – San Antonio, TX

Key Responsibilities
* Lead Quality Assurance for R&D- design, development, V&V phases including hazard/risk analysis and mitigation, DOE and related statistical design and analyses, GDT, design reviews, audits/compliance
* Manufacturing including process development, qualification and validation, IQ, OQ, PQ, part/component selection, sterilization and packaging development and validation
* Develop and implement QA systems to be compliant with applicable international and national standards such as ISO 13485 and regulatory requirements of FDA CFR 820 and other bodies for Class III implantables
* Implement productive relationships with R&D and manufacturing suppliers and partners
* Work in a matrixed organizational structure to support facilities in CA & TX.
* Educate colleagues and support in-house uptake and implementation of these systems organization-wide
* Support the following functions: o Regulatory Affairs o Intellectual Property
* Business and Commercialization, including due diligence documentation
* Implement documentation systems, including electronic systems, under the functional direction of QA Director
based in San Jose

Key Qualifications
* Designed and implemented QA systems for implantable medical devices and drugs. Combinatorial drug-device
and Class III experience desirable. At least 10 years experience, >15 years desirable.
* Bachelor’s degree in Engineering or in an equivalent field required, with ASQ certification (CQE, CRE, CQM, CSSBB) desirable
* Grown QA organizations with a hands-on, leadership- by-example and team-oriented approach
* Demonstrated working experience with electronics hardware and software, biomaterials, drugs, drug delivery, and mechanical technologies while supporting multidisciplinary teams: engineering, biological, manufacturing, regulatory, intellectual property, clinical and business.
* Excellent and demonstrated grasp and use of statistics in R&D and manufacturing including DOE • Supported multiple complex projects and start-ups
* Developed and implemented design controls, documentation, and design procedures, protocols
* Developed and implemented manufacturability, and related process flows and controls, and selected qualified vendors to manufacture Class II and III implantable devices
* Strong technical skills with demonstrated ability to provide hands-on solutions to a variety of technical problems of varying scope and complexity
* Analytical data-driven problem solver and team player, organized and an excellent communicator

Key Job Parameters
* Full-time position located in San Antonio, Texas
* Some travel (~10%) may be necessary to meet job responsibilities
* Report to VP, Product Development

Senior Clinical Data Manager – Dublin, CA

Clinical Supplies Contractor – Dublin, CA

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JOBS — October, 2015


While the job report for this past month was dismal, I have some exciting opportunities.  Please see below some of my immediate opportunities. All US opportunities are for candidates located in the United States only.  But there are some new opportunities located in India (posted in August JOBS), for anyone wishing to do a stint in India, in very exciting, cutting edge multinational.  When sending your resume, please include details on your current compensation and compensation expectations.  Also, include in the email a short summary of your background and your key strengths. Please send resumes to wd_darshana at hot mail dot com.

Director of Quality Engineering – Milpitas, CA

There is an immediate opening for VP of QE for exciting medical device company located in San Jose, CA.  It requires 10+ years experience in implantable device.  Some pharma experience highly desired.  Experience in implementing QE systems, a great plus.  This is very exciting opportunity to be involved in multiple projects with huge upside, in stocks potential.  Requires engineering background.

Director of Manufacturing Engineering – Milpitas, CA

Experience with implantable class III devices, tooling etc. highly desired.

VP of Engineering – Santa Clara, CA

There is an immediate opening for VP of Engineering for design services company, in Santa Clara, CA.

Requirements: Requirements include experience managing hardware and firmware projects including managing several teams of engineers, skill at interfacing with customers including outstanding communication skills & skill at quick understanding of the crux of a problem & solutions.  Although automated process is in place, candidate must have project management skills and experience.  Additionally, the candidate must have skill to understand the customer’s needs and desires, communicate them to engineers & to communicate back to the customer the opportunities & limitations in meeting their goals.

Sometimes, work starts early, before specifications are clear, as the company is called to do feasibility work to determine what can be done or how it can be done.  The company attempts to help customers become successful by requesting specifications or helping them write specifications that are clear and complete enough for senior engineers to complete the work with high quality, on time, and on budget.  It is highly desired to have design experience with hardware (analog or digital), firmware, or software.  It is desired to be skilled at writing proposals.  This is an opportunity to join a small team of high performing engineers and grow the staff as the company grows.

This is a rapidly growing product development company with a reputation for completing difficult projects on time and on budget.  The company designs devices, firmware, and software for other companies and has a track record to respond quickly, provide high quality work, and move on to other projects when done.  The company brings strong experience in working with sensors, wireless, and motion control.  Clients include companies making wearable devices, home health, products for the aging, medical devices, industrial devices, and others in fascinating and challenging fields.

Clinical PK Scientist – Dublin, CA

This position is responsible for overseeing the design, analysis, interpretation and reporting of pharmacokinetic, pharmacodynamic, drug disposition, and drug metabolism data from clinical studies for the oncology portfolio. 

Responsibilities: 

  • Responsible for performing pharmacokinetic analysis and PK and PK/PD modeling and simulations; contribute to relevant sections of Clinical Study Reports, Clinical Pharmacology related regulatory documents and draft relevant sections in support of clinical development plans, and provide Clinical Pharmacology and Pharmacometric perspective on cross-functional teams, including Clinical Study Teams
  • Plan and review study designs, analysis plans, data analysis, and interpretation of PK,  PK/PD, as well as planning, implementation and organization of regulatory filings and presentation of data at cross-functional teams, department meetings, conferences and regulatory meetings
  • Review PK/PD and bioanalytical data
  • Contribute to the design and development of ADME studies as well as the translation of these observations into an understanding of in vivo metabolic fate
  • Work closely with other scientists and disciplines (Biostatistics, Data Management, Translational Pharmacology, Pharmaceutical Development, CMC, Toxicology, Clinical Development, etc.) to plan, analyze and interpret the resulting PK, biotransformation and metabolism data

Qualifications:

  • PhD or equivalent in pharmacokinetics, pharmaceutics, pharmacology or similar area
  • Minimum 3 years’ experience – position title commensurate with experience
  • Hands-on experience with PK analysis and generating outputs gained within a pharmaceutical or biotechnology company
  • Experience with industry standard PK and PK/PD software and tools
  • Strong written, presentation, and verbal communication skills are essential

Post-docs – Engineering – ME, EE, Biochemistry, Pharmaceutical Sciences – CA & TX
Requires excellent and proven hands-on problem solving skills.

Senior Biochemistry Scientist – San Jose, CA
details to follow but feel free to send resume.

Biostatistical Programming Contractor/ Biostatistician – Dublin, CA 

This position will be responsible for providing quality programming & analysis support to the Biometrics & Data Management functions within the Clinical department, of oncology focused company, located in Dublin, CA. This is a contract position for an initial term of 12 months; onsite is strongly preferred but working remotely part time is negotiable.  More details will be posted soon.

Immediate contract Engineering Opportunities – San Jose, CA

  • Electrical Engineering & Software
  • Analog Design
  • PCB Layout (FR4, Flex etc.)
  • ASIC Design
  • Embedded Systems
  • TI MSP430, ARM, Cypress
  • Software (Windows, Linux, C++, Android, iOS)
  • Sensors
  • RF Communications
  • Bluetooth, Wi-Fi, 3G, 4G, GPS
  • Antenna Design
  • RF Test Labs
  • Test Engineering
  • Test Hardware & Software

Opportunities in India are posted in August JOBS posting.

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Harnessing Cloud Technology to improve Customer Engagement for Medical Device


Aroon Krishna and David Judelson, co-founders at VirtuMed talked about the challenging environment for current medical device manufacturers and VirtuMed’s Synapse Mobile cloud based, on-demand, customer engagement platform solution to address the challenges, at a recent www.bio2devicegroup.org event.

Enumerating examples of challenges impacting medical device marketplace, Judelson, said Boston Scientific neuro modulation business has declined due to reimbursement challenges, Medtronic agreed to settle and stop the sales of pain med pump due to link with patient deaths, and big promise and subsequent failure of renal denervation solution has cut the growth among other device manufacturers.  There are challenges across the board from development to commercialization, said Judelson.  Hospitals are faring no better.  Nearly 40% of California hospitals received bad grade, constant M&A activity among hospitals, pressure from changing government initiatives, difficulties with privacy and security of EMR data has all led to medical device companies spending more money to get less and spending more in sales and marketing efforts is not the answer.

Five current headwinds are defining the existing environment.   Increased regulation and declining reimbursement from fee for service to bundling and changes in how CMS pays, is putting a lot of pressure on providers who pass the burden on to device manufacturers.  Second, there is a lot of variability in how different hospitals measure quality.  Third, aging population with increasing co-morbidities is leading to variability in clinical trials and making it challenging to assess the effects of interventions.  Four, challenges are increasing with decreasing hospital access for sales reps.  Five, huge global volatility with large swings in foreign exchange rates, government uprisings etc. is making it hard to estimate earnings.

Hospitals are often burdened with internal challenges of system integration, promise and challenges of mobile technology, problems of achieving seamless inter-operability, thinning margins, vendor management issues, physicians getting overburdened with administrative tasks, HIPPA issues and more.  All these challenges are compounded with sub par performance from medical device companies as they are delivering more failures in R&D, demonstrating lack of innovation with decreased ROI followed by decreasing investment in venture and M&A activity.

Currently, there are few solutions for comprehensive customer management, said Judelson.  Some general solutions like Salesforce, Oracle, imshealth, freshdesk, Veeva and Zendesk have been applied.  However, these require significant customization, often have complex pricing structure, are pricey for small to mid-sized enterprises, have complex IT integration and archaic mobile user interface, and are often based on limited knowledge of medical device econsyste.  There are no existing CRM solutions specially designed for medical device industry, said Judelson.

VirtuMed’s cloud based remote connectivity solution specifically fills in this gap, where device manufacturers can establish direct line with the customer, provide better, more timely customer support as a value added service, develop apps, and leverage knowledge of product users globally with access to real time outcomes data.  There are many gains from such timely information.  Research indicates that with timely physician access to post surgery recovery process and real-time conversation with patients, recovery occurs faster and patients remain more engaged in their recovery.  While there is a great deal of patient to patient interaction in social media, there are fewer tools for patient to provider engagement and that needs to change.

VirtuMed’s Synapse mobile solution helps build a connected ecosystem that combines commercial CRM, social networking, on demand communication, big data visualization, HIPPA compliant infrastructure, and enhances security with data changing hands while ensuring availability of data at the right time to the right people.  This solution aims to unite all key stakeholders on a single platform with primary objective for positive patient impact, said Krishna.  VirtuMed product is poised to offer support to companies of any size and its tech solutions can be applied at each stage in medical device life cycle, from early innovation to clinical stakeholder engagement, to customer engagement to CRM platform to enable growth in emerging markets; literally from ideation to discovery to clinical to commercialization, said Krishna.

The talk with followed with Q&A.

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JOBS – March, 2015


Please see below opportunities and send resume as an attachment to wd_darshana at hotmail dot.  My imminent openings are for Senior Electrical, Mechanical, Quality and Software Engineering and for Technician – all with strong medical device experience.  Please also notice contract opportunities at the end.  All US opportunities are for US based and local candidates.  Opportunities exist in China that are open to all and you can see description in my previous blog at http://bit.ly/15STeDw specific one is for Director of Analytical R&D in Suzhou, China. When sending a resume, please mention job you are interested in, in the subject line and in the email include a brief summary of how best the job description matches your background and where the gaps are.

.jobs -- Cut To The Chase

.jobs — Cut To The Chase (Photo credit: Wikipedia)

Senior Electrical Engineer – Austin/ San Antonio – TX

A company working on innovative range of products, has an immediate opening for senior electrical engineer with class III device experience.  Experience with closed loop, analog design hardware, microcontrollers, actuators  and ultra low power consumption circuit design highly desired.

Key Responsibilities
* Lead Electrical Engineering, primarily for long-term implantable drug delivery devices:
* on R&D- design and development of implantable and associated wearable and external hardware using mixed signal- analog and digital techniques, sensors and actuators and closed-loop control systems
* Manufacturing including process development, qualification and validation, IQ, OQ, PQ, part/component selection, sterilization and packaging development and validation esp for implantable electronics
* Develop Class III implantable electronics to be compliant with regulatory and QA standards (FDA and ISO), as well as be power-efficient, reliable for multi-year operation and pass EMI/RFI, be hermetically sealed and packaged and interface with rest of electronics systems for developed products
* Establish reliable suppliers and partners for manufacturing
* Work in a matrixed and multidisciplinary organizational structure to support multiple projects and technologies following appropriate QA system for each segment
* Document work output and use project and organizational documentation systems, including electronic systems
* Plan for and support existing and projected growth of the company.

Key Qualifications
* Designed and implemented electronics mixed-signal hardware, firmware and software for implantable medical devices and drugs. Combinatorial device and Class III experience desirable. 10-15 15 years desirable
* Bachelor’s degree in Electrical Engineering or in an equivalent field required
* Led and grown EE groups with a hands-on, leadership- by-example approach
* Demonstrated working experience and accomplishments with electronics hardware and software- analog/digital, sensors/actuators. Developed, selected and qualified sensors for both implantable device function and for measuring physiological parameters
* Familiarity and experience with other implantable device components such as connectors, leads, cables, interconnects, headers, electronics packaging, communication protocols and standards. Real-time microcontroller programming a plus.
* Excellent and demonstrated grasp and use EDA tools: sensor/circuit design, simulation, layout. Hands-on re: circuit and system prototyping and development
* Developed and implemented manufacturability, and related process flows and controls. Selected and qualified vendors for manufacturing Class III implantable device electronics.
* Working knowledge of biomaterials, drugs, drug delivery, and mechanical technologies in support of multidisciplinary teams: engineering, biological, manufacturing, regulatory, intellectual property, clinical and business.
* Strong technical and hands-on skills with demonstrated ability to provide solutions to a variety of technical problems of varying scope and complexity
* Analytical data-driven problem solver and team player, organized and an excellent communicator
* Supported multiple complex projects in a start-up environment: able to prioritize.

Key Job Parameters
* Full-time position located near Austin/ San Antonio, Texas
* Some travel (~10%) may be necessary to meet job responsibilities
* Report to VP, Product Development

Senior Mechanical Engineer – Austin/ San Antonio – TX   &   San Jose, CA

A company working on innovative range of products, has an immediate opening for senior mechanical engineer with class III device experience at San Antonio, TX location and at San Jose, CA location.  See details below.

Key Responsibilities
* Hands-on support of Mechanical Engineering, primarily for long-term implantable drug delivery devices:
on R&D- design and development of implantable leads, cans, headers, and overall packaging and assembly of dynamic sensors, actuators, electronics and batteries for long-term (multi-year) use. Develop surgical tools and accessories for implantable systems.
* Manufacturing including materials (plastics, metals) and parts/system selection and qualification, process development: qualification and validation, IQ, OQ, PQ, part/component selection, sterilization and packaging development and validation especially for implantables
* Develop Class III implantables from all aspects of Mechanical Engineering to be compliant with regulatory and QA standards (FDA and ISO) including development and implementation of test fixtures and protocols
* Establish reliable suppliers and partners for manufacturing
* Work in a matrixed and multidisciplinary organizational structure to support multiple projects and technologies following appropriate QA system for each segment
* Document work and input into project documentation systems, including electronic systems
* Plan for and support existing and projected growth

Key Qualifications
* Designed and implemented long-term active implantable medical devices. Combinatorial device and Class III experience desirable. At least 10 years experience, >15 years desirable
* Bachelor’s degree in Mechanical Engineering or in an equivalent field required
* Led and grown ME groups with a hands-on, leadership- by-example approach
* Demonstrated working experience and accomplishments with implantable plastics and metals for connectors, leads, cables, interconnects, headers, electronics packaging, sensors/actuators, and batteries.
* Excellent and demonstrated grasp and use of ME computer-based tools and techniques: SolidWorks, FEA (thermal, strength/structure), 3-D modeling and printing
* Developed and implemented manufacturability, process flows and controls, and selected qualified vendors to manufacture Class III implantable devices using prototyping manufacturing as well as for mass-manufacturing
* Working knowledge of biomaterials, drugs, drug delivery, and electronics technologies and working on multidisciplinary teams: engineering, biological, manufacturing, regulatory, intellectual property, clinical and business.
* Strong technical and hands-on skills with demonstrated ability to provide solutions to a variety of technical problems of varying scope and complexity
* Analytical data-driven problem solver and team player, organized and an excellent communicator
* Supported multiple complex projects in a start-up environment: able to prioritize.

Key Job Parameters
* Full-time position located near Austin/ San Antonio, Texas
* Some travel (~10%) may be necessary to meet job responsibilities
* Report to VP, Product Development

Senior Software/ Algorithm Engineer – Fremont, CA

A company providing innovative diagnostic & therapeutic products &  services to enable interventionalists in providing superior patient care, has an immediate opening for Senior Software Engineer, in Fremont, CA.  Position Summary: This position will be responsible for developing the next generation of image processing algorithms for company’s revolutionary medical devices for cardiovascular business. Individual will participate in object-oriented software development projects using C++ and Qt for a Linux environment. Communicate effectively, as well as to present information to a group in a professional manner. Work cooperatively as part of a team with people from various facilities and technical backgrounds.

Primary Duties and Responsibilities:
Design, develop, and optimize next generation image processing algorithms
Perform lab research and algorithm testing
Develop multi-threaded software for desktop applications
Design code for maintainability and unit tests
Identify, evaluate and mitigate technical project risks
Support formal verification and validation process and participates in transfer of products from R&D to manufacturing
Team player working in a geographically distributed team
Accurately estimate time and resources for completion of specific features/project
Assist in maintaining ISO certification and 510(k) submission requirements

Qualifications & Required Skills:
Minimum BS degree in Computer Science, Computer Engineering, Electrical Engineering, Applied Math, Biomedical Engineering, or related field; Strong background in image processing; 5+ years of software development experience; Excellent coding skills in C/C++; Proficiency in MATLAB; Experience designing object-oriented and distributed software; System level architecture design experienc; Experience with source code management systems like GIT, SVN, Clear Case

Preferred
Experience developing software for medical device applications for user interaction and control
Experience with medical imaging algorithms like segmentation, co-registration, 3d reconstruction
Experience with python, DICOM, OpenGL graphics
Other: * Travel requirements are moderate. Travel to facilities would be about 2 – 3 days duration each trip with total travel expected to be less than 20%.

Please submit resume at wd_darshana at hotmail dot com, with answers to following questions in the email.  This is client HR’s requirement. 
Please provide information on your formal education:
Please describe your software engineering experience as it relates to design, proof-of concept, detailed design, code, unit and integration testing:
Please describe your experience utilizing UML modeling language, DiCom, MFC, BOOST, STL and C++ :
Do you have experience working Linux OS environment? If yes, provide more detailed information:

Senior Design Engineer with Embedded Hardware & Firmware Skills – Santa Clara, CA

A reputed contract engineering company has an immediate full time opportunity for  a Senior Design Engineer with Embedded Hardware & Firmware Skills.  A rounded individual is desired who has an interest and ability in a wide range of technologies.  The successful candidate will lead a group of engineers from time-to-time and may be required to act as the primary interface to the customers at times.  The company designs devices, firmware, and software for other companies and has a reputation for quick response with high quality work.  The person must enjoy working with customers and have good communication skills.  The person must work well on a team of high performing engineers.  The person needs to be organized.  The person must work well with others and be flexible as schedules and priorities change.

Technical requirements: Ten years of experience in embedded system design engineering is required.  Ability to supervise others is highly desired.  The person should have experience designing circuits with microprocessors from PIC to ARM, FPGAs, Bluetooth, and WiFi as well as experience with programming in C or C++ on these devices.  The person must enjoy learning and be able to learn quickly.  The ability to design and program FPGAs is desired.
This could be a work-at-home job, or work at the company site, in Santa Clara, CA.

QUALITY ENGINEER – Santa Cruz, CA

Summary:  Medical device design and manufacturing company, located near Santa Cruz, CA, focusing on custom injection molded plastic parts, has an immediate opening for Quality Engineer.  Position focus is on providing support in the development and maintenance of company’s quality systems, support activities related to the development and qualification of new product development for medical device components and assemblies as well as supporting existing products.
Responsibilities
* Write FMEAs, review and write protocols and reports for new products
* Ability to multitask on a variety of Quality System compliance and improvement initiatives in a hands-on dynamic environment and be involved with the design, procurement, validation and qualification activities including test, inspection and medical device contract manufacturing service processes.
* Responsible for the facility measurement equipment calibration and maintenance program.
* Collects, collates and analyzes manufacturing data for warranty and nonconformance to determine and report product quality trends.
* Conducts analysis of inspection and tests of a routine degree of complexity and provides recommendations accordingly. Develops quality control inspection requirements and techniques to achieve measured improvement. * Implements the Failure Analysis Process for internal and external nonconforming product to determine appropriate corrective action.
* Support Receiving, In- process and Final Inspection of various components and subassemblies for medical device products to support quality compliance and shipment goals as workload requires.
* Assist in the development and implementation of Quality System processes.
* Attend various product meetings with Engineering, Sales, Support, Marketing, and customers to address product requirements, customer concerns and training issues. Work toward and support Company/Department/Team goals including; QSR and ISO compliance, revenues, training utilization, customer satisfaction, and others as appropriate.
* Qualify and implement document changes involving product or process changes
* Coordinate the reporting, analysis, and resolution of material non-conformance incidences
* Provide support in the timely resolution of product complaints and/or safety issues
* Conduct quality audits and develop subsequent preventive action programs
* Assist Regulatory Affairs Department in the preparation of audits and reports for regulatory agencies.
* Perform Supplier Quality Audits and, as appropriate, Internal Quality System Audits; identify root cause of non-compliance and ensure timely/effective corrections and lor corrective preventative actions are implemented
* Drive effective root cause corrective action through internal and supplier surveillance and corrective action requests.
* Report MRB performance metrics and maintain corrective action database.
* Review and report in-process data from manufacturing processes and facilitate corrective and preventive actions

Requirements: 5 – 7 years’ experience in Quality, medical device, regulatory, and or a medical device manufacturing environment; BS in Bachelor of Science in Quality, Business, Mechanical Engineering, Engineering or related field; Certification, CQE, CQA a plus; Experience as an ISO Lead Auditor desirable; Must be able to communicate effectively at varying technical levels with a customer audience; Hands-on manufacturing experience in mechanical or medical device assemblies. CMM, MicroVu, Vision Systems Programming experience; Working knowledge of U.S. and international medical device regulations is desirable Working knowledge of desktop computer office software, Visio Tools, CAD software and e-mail is required; Excellent verbal and written communication skills; Flexibility to handle multiple tasks and meet timelines; Excellent analytical and problem-solving skills combined with a strong technical presence.

Senior Quality Engineer – Austin/ San Antonio – TX

A company working on innovative drug delivery technology has an immediate opening for senior quality engineer. Great opportunity to work at grounds level and grow into leadership role, in addition to the upside of stocks.

Key Responsibilities:
* Lead QA for: R&D- design, development, V&V phases including hazard/risk analysis and mitigation, DOE and related statistical design and analyses, GDT, design reviews, audits/compliance; Manufacturing including process development, qualification and validation, IQ, OQ, PQ, part/component selection, sterilization and packaging development and validation
* Develop and implement QA systems to be compliant with applicable international and national standards such as ISO 13485 and regulatory requirements of FDA CFR 820 and other bodies for Class III implantables
* Implement productive relationships with R&D and manufacturing suppliers and partners
* Work in a matrixed organizational structure to support company’s facilities, including the respective incubated companies, projects and technologies with an appropriate QA system for each segment
* Educate colleagues and support in-house uptake & implementation of these systems organization-wide* Support the following functions: Regulatory Affairs: provide appropriate documentation and materials to support filings for US and international trials and approvals; Intellectual Property: supporting documentation; Business and Commercialization, including due diligence documentation
* Develop & implement documentation systems for these business functions, including electronic systems, with help of to –be-hired Documentation Specialist

Key Qualifications
* Designed and implemented QA systems for implantable medical devices and drugs. Combinatorial device and Class III experience desirable. At least 10 years experience, >15 years desirable*
* Bachelor’s degree in Engineering or in an equivalent field required, with ASQ certification (CQE, CRE, CQM, CSSBB) desirable
* Led and grown QA organizations with a hands-on, leadership- by-example approach
* Demonstrated working experience with electronics hardware and software, biomaterials, drugs, drug delivery, and mechanical technologies while supporting multidisciplinary teams: engineering, biological, manufacturing, regulatory, intellectual property, clinical and business.
* Excellent and demonstrated grasp and use of statistics in R&D and manufacturing including DOE
* Supported multiple complex projects and start-ups: able to prioritize.
* Developed and implemented design controls, documentation, and design procedures, protocols
* Developed and implemented manufacturability, and related process flows and controls, and selected qualified vendors to manufacture Class III implantable devices
* Strong technical skills with demonstrated ability to provide solutions to a variety of technical problems of varying scope and complexity
* Analytical data-driven problem solver and team player, organized and an excellent communicator

Key Job Parameters
* Full-time position located in Austin/ San Antonio, Texas
* Some travel (~10%) may be necessary to meet job responsibilities
* Report to VP, Product Development

Electro-Mechanical Technician – Fremont, CA

A company that develops advanced injection technologies to simplify the complexities of the cardiac cath lab, has an immediate opening for R&D technician.

Requirements
* 9 years of electromechanical technician experience
* 2 year Technical School degree in electromechanics or related field or a combination of education and experience
* 2 years of computer aided design experience
* 2 years experience directing and leading the work of others
* Problem solving skills with the ability to interpret drawings, schematics, and specifications
* Experience using CAD-3D Modeling
* Effective verbal and written communication skills
* Moderate level of computer experience including MS Office Suite and SolidWorks
* Demonstrated experience using a multimeter, soldering iron, oscilloscope, and spectrum analyzer
* High degree of organization skills and high attention to detail
* Ability to prioritize and handle multiple tasks
* Ability to work independently with limited supervision
* Proficient at specifying and evaluating electrical components based on performance, lifetime, and availability
* Demonstrated project management experience
* Demonstrated test report-writing experience

Preferred
* 4+ years of computer aided design experience, * SolidWorks Proficient, * Experience providing technical support to circuit board manufacturing assembly, * Demonstrated knowledge of and familiarity with embedded systems and RF electronics, * Product development experience in a federally regulated engineering environment (FDA, ISO), * Experience defining, writing, and conducting test plans and reports.

Job Description & Responsibilities
Performs specified electromechanical engineering support activities under the guidance of an Engineer or Technical lead related to electro-mechanical design of medical device technologies, product and performance testing, and continuous improvement of the product design. The position is responsible for design, fabrications, assembly, validation, and implementation of development products and fixtures to support the design transfer of products into manufacturing operations.

Primary Duties and Responsibilities:
* Designs fixtures and test methods for validating product design and performance. Responsible for managing the ordering and delivery of fixture components and items from vendors or the internal Model Shop.
* Executes testing and validation protocols, records and analyzes data, and provides written reports to engineering team.
* Supports Product Development efforts at early stages up to design transfer. Provides support to engineers throughout the implementation and development cycles.
* Performs hands on activities such as design validation, pre-production assembly, testing and other technical activities to assist in product development.
* Assists engineers in identifying and resolving hardware design issues. Diagnoses the cause of electrical failures of circuit boards and operational equipment.
* Uses Solid Works CAD system to sketch and design fixtures and devices ensuring form, fit and functional requirements are met. Responsible for basic analysis of design in partnership with an Engineer.
* Responsible for initiating documentation changes and providing redlines to maintain the product information structure. Communicates issues and opportunities to engineering department to ensure bill of material (BOM’s), prints, process, forms, records, etc. are relevant and up to date.

Technical Engineering Support:
* Partners with Designers and Engineer, to develop and improve products, designs, fixtures, and process activities in the interest of continuous improvement and establishment of a Lean environment.
* Initiates design changes and coordinates the change order process to release product per the company’s Quality Management system. Responsible to maintain the design and information structure for use in the ERP system and engineering data base (PDM) DB Works. e.g.; BOM’s, prints, process, forms, records etc.
* Implements changes and maintenance of PDM and CAD systems as required. Assists IT and Technical Documentation Writer in annual CAD system updates, user rights management, and data base management. Creates and edits DB-Works and Solid Works API programs.

IF interested, please send resume with answers to the questions below. The client will only accept resumes, if the questions are answered.
Describe your formal education:
Describe your experience working in medical device or a regulated environment.
Give an example of a work situation where you had minimal supervision and it was critical to work within a fluid or flexible environment.
Describe your experience with developing test fixtures and methods to evaluate a product and/or technology.
Describe your experience developing or using different types of CAD models (or Computer-Aided Design), electrical schematics, or other types of models. (New Q)
Give an example of a product and/or technology project where you had to apply both mechanical and electrical/electronic skills.

 

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JOBS – December, 2014


This is a photo symbolizing the job search in ...

This is a photo symbolizing the job search in today’s economy. Out of the darkness, there seems to be a ray of hope–but where? (Photo credit: Wikipedia)

The year is coming to a close and here is a last blast of opportunities.  Please note: With the exception of the opportunities in China, other opportunities are only for local US based candidates, with valid US work visa.  For the opportunities below, please send resume at wd_darshana at hot mail dot com.  Please indicate in the email how closely the job description matches your background and identify gaps, if any.  Also, indicate your current compensation and compensation expectations.  The opportunities are in the order of priority from most important fresh opportunities to others that are in the process of being filled.

Principal R&D Technician – Fremont, CA

A company that develops advanced injection technologies to simplify the complexities of the cardiac cath lab, has an immediate opening for R&D technician.

Requirements

* 9 years of electromechanical technician experience
* 2 year Technical School degree in electromechanics or related field or a combination of education and experience
* 2 years of computer aided design experience
* 2 years experience directing and leading the work of others
* Problem solving skills with the ability to interpret drawings, schematics, and specifications
* Experience using CAD-3D Modeling
* Effective verbal and written communication skills
* Moderate level of computer experience including MS Office Suite and SolidWorks
* Demonstrated experience using a multimeter, soldering iron, oscilloscope, and spectrum analyzer
* High degree of organization skills and high attention to detail
* Ability to prioritize and handle multiple tasks
* Ability to work independently with limited supervision
* Proficient at specifying and evaluating electrical components based on performance, lifetime, and availability
* Demonstrated project management experience
* Demonstrated test report-writing experience

Preferred
* 4+ years of computer aided design experience, * SolidWorks Proficient, * Experience providing technical support to circuit board manufacturing assembly, * Demonstrated knowledge of and familiarity with embedded systems and RF electronics, * Product development experience in a federally regulated engineering environment (FDA, ISO), * Experience defining, writing, and conducting test plans and reports

Job Description & Responsibilities
Performs specified electromechanical engineering support activities under the guidance of an Engineer or Technical lead related to electro-mechanical design of medical device technologies, product and performance testing, and continuous improvement of the product design. The position is responsible for design, fabrications, assembly, validation, and implementation of development products and fixtures to support the design transfer of products into manufacturing operations.

Primary Duties and Responsibilities:
* Designs fixtures and test methods for validating product design and performance. Responsible for managing the ordering and delivery of fixture components and items from vendors or the internal Model Shop.
* Executes testing and validation protocols, records and analyzes data, and provides written reports to engineering team.
* Supports Product Development efforts at early stages up to design transfer. Provides support to engineers throughout the implementation and development cycles.
* Performs hands on activities such as design validation, pre-production assembly, testing and other technical activities to assist in product development.
* Assists engineers in identifying and resolving hardware design issues. Diagnoses the cause of electrical failures of circuit boards and operational equipment.
* Uses Solid Works CAD system to sketch and design fixtures and devices ensuring form, fit and functional requirements are met. Responsible for basic analysis of design in partnership with an Engineer.
* Responsible for initiating documentation changes and providing redlines to maintain the product information structure. Communicates issues and opportunities to engineering department to ensure bill of material (BOM’s), prints, process, forms, records, etc. are relevant and up to date.

Technical Engineering Support:
* Partners with Designers and Engineer, to develop and improve products, designs, fixtures, and process activities in the interest of continuous improvement and establishment of a Lean environment.
* Initiates design changes and coordinates the change order process to release product per the company’s Quality Management system. Responsible to maintain the design and information structure for use in the ERP system and
engineering data base (PDM) DB Works. e.g.; BOM’s, prints, process, forms, records etc.
* Implements changes and maintenance of PDM and CAD systems as required. Assists IT and Technical Documentation Writer in annual CAD system updates, user rights management, and data base management. Creates and edits DB-Works and Solid Works API programs.

Quality Assurance Manager & Quality Engineer – North San Jose, CA
Quality Engineering background essential for both – more details with follow (feel free to send resume).

Document Control Technician – North San Jose, CA
Details with follow (feel free to send resume).

Director of Operations – North San Jose, CA
Experience running production lines, planning, project management from soup to nuts, people management, experience in quality, GMP, and class III device experience essential.  Full description will follow soon.

Analytical R&D Scientist – TX
Details to follow (feel free to send resume).

Asceptic Process Manufacturing Engineer – North San Jose, CA
Details will be posted soon (feel free to send resume).

Balloon Assembly Manufacturing Engineer – North San Jose, CA
Full description will be posted soon (feel free to send resume).

Engineering Technician with Machning Experience – North San Jose, CA
Description will be posted (am submitting resumes).

Bio Technician – North San Jose, CA
Experience running immunoassays & chemistry assays in a lab plus MS in relevant field required.  More details to follow (feel free to send resume).

Director of Product Portfolio Management – China

A leading biopharmaceutical company in China, with a goal to bring best products at local prices to Chinese populace, has an immediate opening for Director of Product Portfolio Management, in beautiful Suzhou, China. See details below. Compensation includes attractive benefits package + salary + stock options + an opportunity to work in state of the art facility & make real impact.

Requirements:
A candidate must have a Ph.D. degree in Pharmaceutical Sciences, Biology or related disciplines and over 15 years of industry experience (or equivalent) of developing biologics, drug products and new formulations for various therapeutic areas for China and international markets.
* Demonstrated records of leading domestic and international generic drug product development that resulted in recent regulatory approvals in China, US or Europe
* Broad knowledge and experience about biologic drug product development including strategies and approaches, medical and market needs, and regulatory requirements in China and other major markets
* Extensive network with leading researchers in the research institutes and the industry who are engaged in biologics and innovative drug product development
* Excellent written and verbal language skills for communication in both Chinese and English

Responsibilities
This position, based in Suzhou, China, will report to the CEO and be responsible for leading the Product Portfolio Management Department to develop and manage drug product development portfolio for the company. A successful candidate will lead the department to leverage internal and external resources, establish and progress drug product development portfolio in alignment with company’s short term and long term business strategies and objectives.

Additional Responsibilities
* Build and lead the department comprised of functions including patent search, intellectual propriety (IP), product selection, cost analysis, budget planning and project management
* Collaborate with the marketing, medical, regulatory departments and manufacturing facilities to gain in-depth understanding of business needs, regulatory constraints and manufacturing facilities and capabilities
* Lead to establish R&D strategies in alignment with corporate business strategies by fully considering medical needs and marketing trends in different therapeutic areas, business priorities, regulatory constraints and manufacturing facilities and capabilities.

Director of Analytical Research & Development – China 

A leading biopharmaceutical company in China, with a goal to bring best products at local prices to Chinese populace, has an immediate opening for Director of Analytical Research & Development, in beautiful Suzhou, China. See details below. Compensation includes attractive benefits package + salary + stock options + an opportunity to work in state of the art facility & make real impact.

Requirements:
* A candidate should have a Ph.D. degree in analytical chemistry or related disciplines with more than 10 years of industry experience (or equivalent) in providing analytical support to API and drug product development.
* Demonstrated records of leading analytical development that resulted in recent regulatory approvals in China, US or Europe
* Extensive experience of establishing and implementing analytical control strategies (including specifications) and stability studies for innovative or generic drugs developed using scientific and systematic approaches
* In-depth understanding and practical experiences of implementing and operating under quality and regulatory requirements supported by successful passing GMP inspection and pre-approval Inspection
* Excellent written and verbal language skills for communication in both Chinese and English

Overall Responsibilities: This position will report to the Vice President of Quality, & be responsible for establishing and leading the Analytical R&D to support biological API, drug product and new formulation development for technology transfer, clinical supply manufacturing, domestic and international product registration and commercial manufacturing. A successful candidate will lead the department in collaboration with internal stakeholders and external partners to ensure drug product project progression, cost control and timeline while all technical, quality and regulatory expectations and requirements are met.

Additional Responsibilities:
* Establish and lead the Analytical Research and Development Department responsible for providing analytical support to API and drug product development portfolio
* Establish analytical laboratories by designing proper layout, equipping with analytical instrumentation necessary to support API, product and process development
* Build analytical teams with strong expertise to support API development including raw material testing, in-process control, API solid form and particle size control, and release testing as well as drug product development including excipient testing, in-process control and finish product release testing for conventional dosage forms (e.g., oral solid IR and MR, sterile products) and innovative drug delivery systems
* Implement standard operating procedures (SOPs) and best practices for analytical development activities and ensure technical, quality and compliance requirements are met
* Direct and ensure analytical project teams establish analytical control strategies, develop, qualify and validate analytical methods for API and drug product development, clinical supply manufacturing, registration and commercial manufacturing
* Project, identify, allocate and manage internal and external resources (including academic research institutes, CROs, and parent companies) needed to deliver analytical support to meet established timeline within budget
* Support regulatory submission, query responses and pre-approval inspections to ensure regulatory approvals
* Establish a good working relationship with regulatory agencies in China and other major markets. Participate and lead technical based engagement such as dialogues with regulatory agencies through industry associations
* Initiate and lead technical collaboration with external partners (including academic research institutes, CROs, and parent companies) to develop new analytical technologies or novel applications
* Provide technical assessment including due diligence to support business development opportunities
* Develop a training program for the department to ensure all essential training needs for technology, quality and compliance are provided

Director of Quality Assurance – Suzhou, China

A leading biopharmaceutical company in China, with a goal to bring best products at local prices to Chinese populace, has an immediate opening for Director of Quality Assurance, in beautiful Suzhou, China. See details below.
Reports to Corporate Legal Representative (as specified by law in China)
Direct reports – Manager of Documentation

Requirements: BS and 10+ years experience in QA for monoclonal antibodies & other recombinant proteins. Should be technical expert in QA & cGMP compliance including technical issues related in the manufacturing, testing & characterization of recombinant proteins; must have technical background to evaluate issues based on the science and not rely solely on historical precedent; must have experience in development of biopharmaceutical products for registration in the US and Europe, including experience in the preparation of documents that support regulatory submissions. Chinese language skill is a plus.

Responsibilities: Oversee Quality Assurance functions pertaining to release of drug substance & drug products; responsible for the controlled document system and the documents within the system including batch records, SOPs, validation records & other controlled documents; translating goals into action plan. Also responsible for staff development including cGMP training; ensure compliance with company policies & maintain safe work environment.

 

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JOBS – October, 2014


For the opportunities below, please send resume at wd_darshana at hotmail dot com.  Please indicate in the email how closely the job description matches your background and identify gaps, if any.  Also, indicate your current compensation and compensation expectations.  Please note: With the exception of the opportunities in China, other opportunities are only for local US based candidates, with valid US work visa (when need arises for applicants from other countries, I mention that under that specific opportunity).

Director of Product Portfolio Management – China

A leading biopharmaceutical company in China, with a goal to bring best products at local prices to Chinese populace, has an immediate opening for Director of Product Portfolio Management, in beautiful Suzhou, China. See details below. Compensation includes attractive benefits package + salary + stock options + an opportunity to work in state of the art facility & make real impact..

Requirements:
A candidate must have a Ph.D. degree in Pharmaceutical Sciences, Biology or related disciplines and over 15 years of industry experience (or equivalent) of developing biologics, drug products and new formulations for various therapeutic areas for China and international markets.
* Demonstrated records of leading domestic and international generic drug product development that resulted in recent regulatory approvals in China, US or Europe
* Broad knowledge and experience about biologic drug product development including strategies and approaches, medical and market needs, and regulatory requirements in China and other major markets
* Extensive network with leading researchers in the research institutes and the industry who are engaged in biologics and innovative drug product development
* Excellent written and verbal language skills for communication in both Chinese and English

Responsibilities
This position, based in Suzhou, China, will report to the CEO and be responsible for leading the Product Portfolio Management Department to develop and manage drug product development portfolio for the company. A successful candidate will lead the department to leverage internal and external resources, establish and progress drug product development portfolio in alignment with company’s short term and long term business strategies and objectives.

Additional Responsibilities
* Build and lead the department comprised of functions including patent search, intellectual propriety (IP), product selection, cost analysis, budget planning and project management
* Collaborate with the marketing, medical, regulatory departments and manufacturing facilities to gain in-depth understanding of business needs, regulatory constraints and manufacturing facilities and capabilities
* Lead to establish R&D strategies in alignment with corporate business strategies by fully considering medical needs and marketing trends in different therapeutic areas, business priorities, regulatory constraints and manufacturing facilities and capabilities

Director of Analytical Research and Development – China

A leading biopharmaceutical company in China, with a goal to bring best products at local prices to Chinese populace, has an immediate opening for Director of Analytical Research & Development, in beautiful Suzhou, China. See details below. Compensation includes attractive benefits package + salary + stock options + an opportunity to work in state of the art facility & make real impact.

Requirements:
* A candidate should have a Ph.D. degree in analytical chemistry or related disciplines with more than 10 years of industry experience (or equivalent) in providing analytical support to API and drug product development.
* Demonstrated records of leading analytical development that resulted in recent regulatory approvals in China, US or Europe
* Extensive experience of establishing and implementing analytical control strategies (including specifications) and stability studies for innovative or generic drugs developed using scientific and systematic approaches
* In-depth understanding and practical experiences of implementing and operating under quality and regulatory requirements supported by successful passing GMP inspection and pre-approval Inspection
* Excellent written and verbal language skills for communication in both Chinese and English

Overall Responsibilities: This position will report to the Vice President of Quality, & be responsible for establishing and leading the Analytical R&D to support biological API, drug product and new formulation development for technology transfer, clinical supply manufacturing, domestic and international product registration and commercial manufacturing. A successful candidate will lead the department in collaboration with internal stakeholders and external partners to ensure drug product project progression, cost control and timeline while all technical, quality and regulatory expectations and requirements are met.

Additional Responsibilities:
* Establish and lead the Analytical Research and Development Department responsible for providing analytical support to API and drug product development portfolio
* Establish analytical laboratories by designing proper layout, equipping with analytical instrumentation necessary to support API, product and process development
* Build analytical teams with strong expertise to support API development including raw material testing, in-process control, API solid form and particle size control, and release testing as well as drug product development including excipient testing, in-process control and finish product release testing for conventional dosage forms (e.g., oral solid IR and MR, sterile products) and innovative drug delivery systems
* Implement standard operating procedures (SOPs) and best practices for analytical development activities and ensure technical, quality and compliance requirements are met
* Direct and ensure analytical project teams establish analytical control strategies, develop, qualify and validate analytical methods for API and drug product development, clinical supply manufacturing, registration and commercial manufacturing
* Project, identify, allocate and manage internal and external resources (including academic research institutes, CROs, and parent companies) needed to deliver analytical support to meet established timeline within budget
* Support regulatory submission, query responses and pre-approval inspections to ensure regulatory approvals
* Establish a good working relationship with regulatory agencies in China and other major markets. Participate and lead technical based engagement such as dialogues with regulatory agencies through industry associations
* Initiate and lead technical collaboration with external partners (including academic research institutes, CROs, and parent companies) to develop new analytical technologies or novel applications
* Provide technical assessment including due diligence to support business development opportunities
* Develop a training program for the department to ensure all essential training needs for technology, quality and compliance are provided

Director of Quality Assurance – Suzhou, China

A leading biopharmaceutical company in China, with a goal to bring best products at local prices to Chinese populace, has an immediate opening for Director of Quality Assurance, in beautiful Suzhou, China. See details below.

Reports to Corporate Legal Representative (as specified by law in China)
Direct reports – Manager of Documentation
Requirements: BS and 10+ years experience in QA for monoclonal antibodies & other recombinant proteins. Should be technical expert in QA & cGMP compliance including technical issues related in the manufacturing, testing & characterization of recombinant proteins; must have technical background to evaluate issues based on the science and not rely solely on historical precedent; must have experience in development of biopharmaceutical products for registration in the US and Europe, including experience in the preparation of documents that support regulatory submissions. Chinese language skill is a plus.

Responsibilities: Oversee Quality Assurance functions pertaining to release of drug substance & drug products; responsible for the controlled document system and the documents within the system including batch records, SOPs, validation records & other controlled documents; translating goals into action plan. Also responsible for staff development including cGMP training; ensure compliance with company policies & maintain safe work environment.

Project Manager – Pleasanton, CA

Innovative medical device company located in Pleasanton CA, has an immediate opening for hands-on project manager.  Experience with drug coated medical devices, drug coated balloon catheters, drug coated stents etc. highly preferred.  Also preferred mix of high level contributor who can work in the lab, doing studies, testing, process improvements, documentation etc. will be highly desirable.  Salary will be competitive and range between $120 to $150 K base, plus bonus.

Senior Electrical Engineer with Implantable Device Experience – Fremont, CA
There is an immediate opening in an exciting startup with innovative technology with a huge potential.  Requirements: EE background, medical device experience, and circuit design, FPGA, Verilog design, and schematic drawing experience required.  Need to be hands-on and will be working on a controller.  Pay will be in $130K range.

Catheter Engineer – Fremont, CA
Innovative medical device startup, located in Fremont, has an immediate opening for catheter engineer with 5-10 years baloon catheter development experience.  Salary will be commensurate with experience and will be in $100-$130 range.

Senior Manufacturing Engineer/ Manager – Sunnyvale, CA
Requirements include: Class 3, implantable, catheter, drug device combination products type of medical device experience.

Project Manager – Pleasanton, CA
Immediate opening for senior level project manager with medical device background.  Class III, drug coated device experience absolutely required.

Senior Python Automation Engineer – CA
There is an immediate opportunity for Senior Python Automation Engineer with 3+ years of Network Engineering experience (In Layer 2 and Layer 3 of networking protocols and features).

Biostatistician: Southern CA
There is an immediate opening for Biostatistician, with an innovative medical device company, located in Southern CA.  The position requires clinical experience.  The company is a leading developer of emerging microelectronic technologies that modulate nerve activity to treat disabling disorders, including chronic pain, depression, urinary incontinence and so on.

.jobs -- Cut To The Chase

.jobs — Cut To The Chase (Photo credit: Wikipedia)Highly innovative medical device company with cutting edge products to impact the quality of care, has an immediate opening for Biostatistician.  The company is a leading developer of emerging microelectronic technologies that modulate nerve activity to treat disabling disorders, including chronic pain. The company is investigating a number of innovative DBS technologies to treat other neural disorders, including migraine headaches, depression, Parkinson’s tremors, urinary incontinence, and erectile dysfunction.

Key Responsibilities:
– Act as a leader and subject matter expert for clinical study design and analysis.
– Collaborate with the rest of the Biostatistics & Data Sciences group on developing data collection and analysis strategies.
– Work closely with the Research Scientist, Project Manager, and Medical Director on development and execution of a range of clinical programs, including Feasibility, Pivotal, and Post-Market.
– Effectively communicate recommendations based on complex statistical concepts to Senior Leadership.
– Oversee and ensure the statistical integrity of all clinical programs.
– Lead the development and oversee the execution of the statistical analysis plans.
– Oversee the activities of the supporting Statistical Programmers in their implementation of statistical analysis plans.
– Represents Biostatistics on study teams and communicates with management and other team members regarding project/study status and timeline update
– Lead publication efforts in regards to data analysis and study results.
– Ensures the quality-controlled production of all tables, listings and graphs for clinical documents and publications.
– Independently lead research projects based on theoretical methodologies and/or publicly-available datasets to drive publications related to Biostatistics.
– Develop meta-analysis for existing clinical literature to enable data-driven strategic decisions for clinical program development and to support regulatory submissions.
– Collaborate with non-clinical colleagues (e.g. R&D, Marketing) on special projects.

Requirements
– Ph.D. in Biostatistics/Statistics or a field with a comparable quantitative/statistical emphasis
– 2 years experience in Biostatistics/Statistics research
– Excellent analytical and decision-making skills
– Excellent communication and presentation skills
– Strong independent statistics research skills
– Intermediate knowledge of SAS programming
– Excellent knowledge of experiment design and data analysis.

Marketing Product Manager – Southern CA

Global medical technology company and a leading developer of microelectronic technologies that modulate nerve activity to treat disabling disorders, including chronic pain has an immediate opening for Product Manager, at its Southern CA location. The Marketing Product Manager will be involved in all aspects of developing and launching devices.

Principle activities include:
– Working closely with cross-functional product development teams and generating voice-of-the-customer marketing specifications for product development
– Collecting feedback from customers throughout product development
– Supporting product commercialization activities across multiple internal and external groups such as design, packaging and labeling, regulatory claims, surgical technique generation, sales force education and operations planning.
– Developing and conducting market research
– Acquiring and analyzing feedback from key opinion leaders, current and potential customers, third party market research and internal stakeholders
– Possessing an in-depth knowledge of the healthcare industry in general and more specifically, the segments targeted by assigned products
– Participating and supporting a comprehensive launch plan and strategy for new product(s)
– Creating and implementing market development strategies to target key customers
– Developing product positioning, marketing messaging, and related marketing collateral
– Establishing relationships with key opinion leaders in the field
– Developing sales and physician education program

Requirements:
EDUCATION:
– M.B.A. or advanced degree strongly preferred
– Minimum BS degree.
– Degree in engineering or life sciences a plus
EXPERIENCE:
– 1+ years minimum experience of increasing responsibility in a marketing role
PREFERRED EXPERIENCE AND ABILITIES:
– Medical device industry experience strongly preferred; experience with Class III devices preferred. Technical or neurostimulation research focus.
– New product development or product management experience preferred
– Previous product launch experience
– Strong analytic and strategic thinking ability
– Ability to complete assignments of an advanced degree of complexity, working under little supervision on specific tasks or projects

Solidworks Drafter/ Designer – Southern, CA

Review and verify drawings Per ASME Y14.5M-2006 and Corporate Standard using ePDM system. Provide drafting and tool design support to the manufacturing, equipment design, process development groups. Create all appropriate mechanical drawings and appropriate documents. Create and implement technical studies & equipment installation qualifications.

– Model product concepts using current tool, analysis techniques, and technologies through use of parametric CAD software and other mechanisms. Designs components or portions of systems and modifies existing designs to develop or improve products and facilitate manufacturing operations.
– Perform Mechanical design/redesign of medical device products applying industry standards (e.g. ASME Y14.5M-1994) to detail drawings. Drafts tools and /or machines of varying types for use in the manufacture of company products.
– Create/modify/maintain documentation using tools that are tied to a data management system. Utilizes computer-aided design equipment and/or graphic tools such as, CAD, CAM or Solid Works.
– Provide support for OEM device documentation and Bill of Material structure support.
– Completes document packages by detailing parts and creating BOM and schematics following layouts, sketches and verbal instructions to ensure that all of the needed documentation is available for manufacturing process. Gathers information, makes studies, computes calculations, and prepares original rough layouts, sketches to present design proposal.
– Reviews and verifies design work of peers to check for compliance with standards and corporate procedures. Coordinates design criteria with engineering, manufacturing, tooling, material, and planning group such as ease of manufacture, availability of materials, and contractual specifications.
– Recommend: May review engineering order (EO) package by reading information on EOs (e.g. document description) and supplemental information (e.g., preliminary sketch) in order to identify missing information.
– May generate engineering change orders (ECOs). (CRM)
– May provide illustrations, animation and web publishing solutions that allow communication of 2D/3D product information for interactive assembly, maintenance/ restoration of documentation, product presentations and Federal and International compliance.
– Prepares and implement installation qualification protocols, and preventive maintenance procedures.
– Set up new equipment, ensures its satisfactory operation and instructs others to use the equipment properly.
– Participate in a team environment to enhance processes and product performance.

Minimum Qualifications:
– 5 years of experience working with SolidWorks in designing fixtures and tools.
– Familiar with ePDM
– Good understanding of the ASME Y14.5M

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JOBS – May, 2014


For the opportunities below, please send resume at wd_darshana at hotmail dot com.  Please indicate in the email how closely the job description matches your background and identify gaps, if any.  Also, indicate your current compensation and compensation expectations.  Please note: All below opportunities require several years of industry experience and are only for local candidates, with valid US work visa (when need arises for applicants with other types of visas, I will mention that under that specific opportunity).  Also note, opportunities at the top are hot and the ones lower down may be at various stages of being filled or not burning needs.  This quarter seems to be all about Engineering Jobs (more specifically in Software), but Quality Engineering and CRA opportunities in New York, New Jersey and San Jose, CA are also very hot.    – see below.

Software   Developer – Mountain View, CA

Right now we are witnessing the onset of industrial internet paradigm where integration of big data with big machines is fundamentally changing everything.  This company provides innovative, modular, scalable and world class software solutions in this industrial-internet paradigm by leveraging sensor technologies, cloud computing, big data analytics and complex event processing.  There is an immediate opening for software developers with Windows skills.

Responsibilities: Be involved in all stages of SDLC, including analysis, design, implementation, testing, documentation & release; Participate in multiple projects with changing requirements; Maintain contact with clients/partners to       provide solution support& updates; Be ready to learn new technologies quickly.

Requirements: 4+ years of software development experience in  ASP.NET with MVC, JQuery; Be comfortable in data modeling, developing  stored procedures & triggers; Windows Communication.  Also preferred: Windows workflow foundation  4.0; Biztalk RFID server; Windows Mobile development; Exposure to Windows Azure

Location: SF Bay Area. Telecommute okay, but may need to attend client meetings: 6-12 months to full time.  Pay rate: $65 an hour but negotiable based on experience.

Test Engineer – SF Bay Area

Right now we are witnessing the onset of industrial internet paradigm where integration of big data with big machines is fundamentally changing everything.  This company provides innovative, modular, scalable and world class software solutions in this industrial-internet paradigm by leveraging sensor technologies, cloud computing, big data analytics and complex event processing.  Below is description for Test Engineer with the company.

Responsibilities: Be involved in all stages of SDLC: including analysis, design, implementation, testing, documentation & release; Participate in multiple projects with changing requirements: Maintain contact with clients/ partners to provide solution support & updates; Be ready to learn new technologies quickly.

Requirements: 4-6 years of software development experience in ASP.NET with MVC, JQuery; Be comfortable in data modeling, developing stored procedures & triggers, Windows Communication.  Also preferred: Windows workflow foundation 4.0; Biztalk RFID server; Windows Mobile development; Exposure to Windows Azure.

Location: SF Bay Area or Austin, TX.  Telecommute possible, 6-12 months to full time.  Pay rate: $35 per hour but negotiable based on experience.

Junior & Senior CRA – Orangeburg, NY

Medical device company with innovative treatment for chronic heart failure, located in Orangeburg, NY, has openings for Jr & Sr. CRA.  (Awaiting JD for Senior CRA but feel free to send resumes).

Junior CRA

Functions: Manage & organize administrative aspects in clinical department, create & maintain site personnel contact information, mass mailings, study binder preparation & distribution; Collect regulatory documents, ensure accurary, record reciept of key documents & contact site regarding missing records; Collect & Review study-related tracking systems to determine & report status of clinical trial documents. Send notifications to the clinical trial sites regarding their IRB renewal dates IRB; Maintain & audit study related files in compliance with department standard operating procedures; Review monitoring reports & assist with the follow-up & resolution of noted observations; Work with clinical trial sites to ensure all required testing is forwarded to & received by the Core Laboratories; Consistently use study tools & training materials & comply with standard operating procedures and policies; Perform data entry; Arrange periodic meetings for the Physician Adjudication Committee & assist the Clinical Director with the preparation & conduct of the meetings.

Requirements: Bachelor’s degree in life sciences or related, with 1-2 years medical device clinical research experience; Experience in communicating with hospital administrators and clinical research nurses; Working knowledge of FDA regulations and Good Clinical Practices; Excellent organizational skills; Good problem solving skills; EDC experience a plus; Conscientious person with an outstanding work ethic & strong personal discipline.


Quality Engineering opportunities- Middleton, MA

A company located near Middleton, MA, and recognized as a pioneer & global leader in healthcare technology & innovation for assisting or replacing the life-sustaining pumping function of the failing heart, has following immediate Quality Engineering opportunities.

Quality Engineer – Console Program Support

Requirements:  Bachelors in EE & 5+ years implantable medical device experience and Design Control & risk management experience required.  CQE or CRE certifications are preferred.  Comp: $80-95K
Functions: Understand customer complaint trends & patterns for root cause understanding & corrective actions; Program support for console includes review of design/software verification & validation protocols & reports; conduct design control compliance reviews, performs risk analysis, and FMEAs; Instill reliability mindset within team & provide guidance on reliability methods to team.

Quality Engineer – Disposables Program Support

Requirements:  Bachelors in EE highly desirable.  1 year medical device experience & CQE or CRE certifications are highly preferred. Comp: $60-85K
Functions: Understand customer complaint trends & patterns for root cause understanding & corrective actions; program support on heart pump disposables including review of design & process verification and validation protocols & reports; conducts design control compliance reviews, performs risk analysis, and FMEAs.


QA Manager – Mount Laurel, NJ

JOB Toulouse

JOB Toulouse (Photo credit: JiPs☆STiCk)

An innovative medical device company working on treatment of chronic heart failure (“CHF”), has an immediate opening for a QA Manager.  Salary commensurate with experience and will be in the range of $125-145K.

Responsibilities: Management of Quality Systems department; Direct supervision of Shipping Coordinator and Documents control; Day to day operation of all quality functions; Assure compliance with domestic and international quality requirements; Ensure comprehensive Quality Systems programs to support multiple product manufacture; Prepare and execute all external & internal audits; Work with contract manufacturer to ensure that devices are manufactured in compliance with US and international quality system requirements; Review all product complaints & ensure timely reporting of those events to domestic and international regulatory agencies as necessary; Participate in product development teams on behalf of Quality Systems. Identify and resolve quality issues throughout product development process to assure successful audits and regulatory filings; Manage, supervise and train staff, oversee projects ongoing within departments, carry out departmental administrative duties; Review and revise quality system documentation to ensure compliance with domestic and international quality and regulatory requirements; Schedule and complete timely management review presentations; Manage the document services function to ensure that quality systems documents, records and regulatory submissions are controlled; Schedule, conduct and assist in responding to internal audits; Schedule and conduct supplier audits; Maintain program to ensure adequate training of personnel on quality system documentation; Ensure that company employees are trained on the Quality Systems Regulation and key international regulations and standards; Manage the program for handling product returns, returned product evaluations (and repair/rework, where applicable), complaints and customer feedback in accordance with internal policies and procedures; Maintain a functional CAPA system in compliance with applicable regulations; Maintain ISO 13485:2003 facility registration in accordance with applicable standards; Provide guidance and supervision for Shipping/Receiving Clerk as it relates to completion of receiving inspections and other quality related functions; Ensure that the Quality Systems function is carried out in accordance with GMP and ISO directives.

Requirements: Minimum Bachelors level degree with 8-10 years’ experience in Quality area or related experience in medical device arena; Good working knowledge of domestic and international requirement and regulations; Excellent organizational skills and analytical and problem solving abilities; Strong verbal and writing skills and good interpersonal and leadership skills; Strong PC skills include Windows environment, Excel and internet.  Spanish language skills desirable.


Senior Manager Quality Engineering – San Jose, CA

There is an exciting opportunity for Senior Manager, Quality Engineering with strong capability and experience developing quality innovative medical devices.  This position is responsible for effectively leading multi-project quality engineering efforts of the organization through technical expertise, interpersonal skills and a clear vision for execution.

Responsibilities: Manage resources to accomplish multi-project product research, development and manufacturing; Contribute to strategy and management of GMP/GLP operation; Provide Quality Engineering support as necessary to meet organizational objectives; Maintain quality management systems necessary for development, including clinical evaluation; Develop quality plans and data analyses for execution and review with leadership team; Develop test strategies DOEs and test protocols to test developmental medical devices and manufacturing processes; Work with R & D and Operations to establish quality requirements at all phases of product/process development and manufacturing; Design, schedule, and if necessary, performs specific testing for existing and new products including supporting design and process validations, qualifications and first article inspections; Conducts supplier evaluations including supplier audits; Ensure that appropriate level of quality/reliability in purchased components is specified; Identify product/process problems and ensure appropriate corrective actions are taken and verified to be effective in eliminating problem; Remain current on developments in field(s) of expertise and industry trends; Mentor junior staff members

Skills Required: Demonstrated leadership of technical teams in medical device field; Demonstrated aptitude for and mastery of Quality Engineering principles; Demonstrated problem solving skills in a multidisciplinary environment; Exemplary analytical, organizational, written and oral communication skills; Proficient with statistical analysis for engineering and manufacturing; Strong ability to operate independently and as a team member; Teamwork: ability to work closely and effectively with team members and colleagues across engineering as well as non-engineering disciplines such as biochemistry, physiology, pharmacology and chemistry; Knowledge of implantable medical device design control and manufacturing processes ; Deep experience in safety standards for a variety of medical device types; Knowledge of biocompatibility, packaging and sterilization quality assurance; Demonstrated ability to interface effectively with professionals in the medical and biological sciences; Demonstrated knowledge of sound design principles, regulatory requirements, and product and process validation procedures; Demonstrated proficiency with computer aided design software and hardware familiarity. Formal training on systems and software is desired.

Also required: Bachelor’s degree or higher in Engineering; Ten years minimum experience in medical device engineering (Quality, R&D and Manufacturing) with demonstrated capability and thorough understanding of quality management; Three years minimum direct personnel management and related leadership experience; ASQ Certified Quality Engineer certification preferred; Must have experience in GMP electro-mechanical product design and manufacturing; Requires highly developed leadership skills and experience, including the ability to map task interdependencies, multi-task, prioritize such tasks, meet deadlines, and develop, monitor and live within budgets as well as the demonstrated ability to forecast major milestones.  Must be skilled at delegation, follow-up, and team building.

Machine Learning/ Computer Vision Software Engineer – Mountain View, CA 

There is an immediate opening with a company working to quickly get life saving technology to market.  Company offers an excellent benefits plan, and grants stock options to all employees.

Responsibilities:  Work on challenging problems in computer vision and machine learning that will have a direct impact globally on the healthcare and safety of patients; Research, prototype & develop novel computer vision and machine learning algorithms; Work within a cross-functional team of computer vision, software, hardware and mechanical engineers in a medical device environment

Requirements: Expertise in machine learning algorithms (classification and clustering) for pattern recognition: Decision trees, Support vector machines, Neural networks Expertise in Computer / Machine Vision, Feature extraction, Segmentation, Color and shape analysis, Object and character recognition Hands-On Expertise in Open CV, MATLAB, C++ or C#.  Also required, M.S. or Ph. D in Computer Science with a focus on computer vision and/or machine learning; Strong skills in machine learning & computer vision, with a deep understanding of the methods & algorithms used in this domain; Strong analytical & problem solving skills; Track record of hypothesis driven experimentation & problem solving; Up to date with the latest publications in the machine learning and computer vision community; Excellent written and verbal communications and the ability to work hands-on in cross functional teams; Highly motivated and excited to work in a fast-paced environment.

Senior Firmware Engineer  (Mountain View, CA)

There is an immediate opening with a company working to quickly get life saving technology to market. This industry-leading technology platform (image processing, computer vision, pattern recognition, embedded software, hardware, and firmware) was built internally.  This is a challenging environment with simultaneous multiple projects, aggressive deadlines and A+ team. Company provides excellent benefits plan, and grants stock options to all employees.

Responsibilities: Programming for embedded systems that utilize wireless communication channels, including Bluetooth, 802.15.4 radios, RFID and WiFi, Validate design concepts by designing, fabricating & debugging prototypes, Conduct & coordinate firmware testing activities, including unit testing, functional testing & regression testing, Support manufacturing by developing manufacturing test procedures, Collaborate on firmware architecture design strategies & requirements, Support product by creating & by composing functional & design documentation

Requirements: Proficient in high-level structured programming languages (e.g. C, C++); Proficient in Ultra-low Power Design techniques, Proficient in Wireless Communication techniques, Proficient is Motor Control Systems and State Machines, Skills for both implementing new firmware systems as well as analyzing and modifying firmware systems originally written by others, Proficient in developing code with resource-limited runtime environments, for embedded products, Proficient in low-level languages (e.g. Assembler, ladder) is a plus; Bachelors or Masters in Electrical Engineering and 5+ years of relevant experience.

Senior Java Software Engineer  (Mountain View, CA)

This is an immediate opening with a company working to quickly get life saving technology to market. This industry-leading technology platform (image processing, computer vision, pattern recognition, embedded software, hardware, and firmware) was built internally.  This is a challenging environment with simultaneous multiple projects, aggressive deadlines and A+ team. Company provides excellent benefits plan, and grants stock options to all employees.

Responsibilities: Design & implement company’s suite of products & distributed web applications using J2EE, Spring Framework, XML, Web Services, JMS, Servlets, JSP/JSF, and Hibernate; Design & implement easy-to-use, high-performance, high-quality, embedded, hosted & enterprise web-applications; Design & implement development platform & complex applications with limited or no direct supervision; Flexible & works well as part of a fast-paced interdisciplinary product development team

Requirements: Strong object-oriented analysis and design skills; Strong analytical skills & attention to detail; Proficient with physical &  logical database design; Understand advanced relational database concepts; strong sense of project ownership; Knowledge of Scrum & XP methodologies; Apt learner of new software technologies & can research a variety of third party solutions which might fit problems on hand; Visual design skills for web page design & layout a plus.  Also required, 4+ years experience in OO analysis, design, & implementation; 4+ years experience in server side Java development using J2EE technologies, Spring, XML, Web Services, JMS, JSP, JavaScript, CSS, AJAX; 4+ years experience in at least one relational database management system; Experience in interfacing with databases from Java (Hibernate / Java Persistence API, etc.); 4+ years experience in industry-standard software development methodologies, e.g. use case-driven and test-driven iterative software development methodologies; 4+ years experience in debugging, code-reviewing, code-refactoring, performance tuning; 4+ years experience with a variety of OSs such as Windows, Solaris and Linux.  Also preferred: Experience developing Web Services and REST-based communication interfaces; Experience with large-scale back-end systems, AWS, cloud apps or APIs; Specific familiarity with JUnit and JMock is a plus; Specific familiarity with JQuery is a plus. Required: MS or Ph.D. in computer Science.


Senior Embedded Development Programmer – Mountain View, CA

A top notch product development company with a reputation for completing difficult projects on time and on budget, has an immediate opening for a programmer. The company consults for companies making wearable devices, home health, products for the aging, medical devices etc & is known for work with sensors, wireless, and motion control.

Requirements:  10+ years experience in engineering design; Embedded programming skills on Windows and/or Linux; Experience with wide range of processors; Familiarity with digital circuits; Ability to design digital circuits. Ability to design analog circuits & supervisory experience would be a plus. The person needs to enjoy working with customers and have good communication skills.  The person needs to work well on a team of high performing engineers.  The person needs to be organized.  The person needs to work well with others and be flexible as schedules and priorities change.

Post Doc Opportunity – TX & CA 

There are immediate exciting opportunities that can lead you a fantastic career path in medical device engineering.  A medical device company, found by a veteran leader of several successful companies, has several post-doc openings in Biomedical with Electronics/ Electrical Engineering – with experience in heart/ brain related implantable devices in Texas and couple of opportunities with broad Biomedical/ Mechanical and/or Chemical Engineering background.  Hands-on experience is essential.  For Electronics Engineering, experience with hands-on circuit design, embedded systems design, prototype building or experience with battery-powered, low powered systems, etc. may be desirable.  The company is working on exciting cutting edge technology to deliver large drug molecules orally.  That and other research products pertain to solutions that are a unique blend of traditional device technologies such as electronics, software, mechanical engineering, and material science, as well as pharmaceuticals, protein chemistry and cell biology.  Focusing on a broad range of technology and scientific disciplines, the company is seeking to address most complex unsolved or poorly treated clinical needs with highly innovative novel solutions.

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If you are a professional  in #healthIT, #digital health,  #internetofthings, #cloud, #bigdata or related, I would say this is the conference, you don’t want to miss – It gives fabulous opportunity to network with 4000+ professionals. Check out great agenda, top notch speakers & panelists at www.tiecon.org.  Register for #TiEcon (May 16 & 17 at Santa Clara Convention Center) at link http://tinyurl.com/kr2hkcw  as my guest & enter promo code tievalue to get $100 discount (valid till midnight, May 1).

Healthtechnology conference http://www.healthtechnologyforum.com, focused on exploring pathways to sustainable health, is on May 20 in SF. Please register for the conference as my friend, with the discount code “HTF14-FriendOfOrganizer” and send me your first & last name at wd_darshana at hotmail dot com, to get $150 off the price of the ticket.

http://www.bio2devicegroup.org meets every Tuesday in Sunnyvale, CA.  Morning meetings are free, wealk-ins welcome. If you would like to speak at one of our events, or for more information on any of our events, feel free to send me an email at wd_darshana at hotmail dot com and you can follow my updates on Twitter @DarshanaN.

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Cloud-based eClinical Systems – Myths, Challenges & Opportunities


Al Gicqueau, CEO & President at Clinovo talked about Cloud-based eClinical Systems to make clinical trial process more efficient and cost-effective, at www.bio2devicegroup.org event.

Cloud has been a big buzz word, significantly impacting the economy, in the last few years.  Cloud is growing 3X faster than traditional internet infrastructure, said Gicqueau.  Worldwide public cloud services market will total to over $73 billion, by 2017.  There is also simultaneous cloud-bashing.  According to Citrix research, majority of the Americans don’t understand it and over 51% think it has something to do with the stormy weather.  Most also believe they have never used it but over 95% of us have used cloud based services.

It is therefore important to understand what constitutes cloud based services.  There are 5 essential components of cloud based services.
Self Service, On Demand: Cloud based services are available, when the consumer needs them.  Further, for the most part  they are autonomous and the user can perform the actions without going through the IT department.  They are easy to use and on-site training will increasingly become a thing of the past.  Any training required has to be available on-line and has to be very short and for the most part the service has to be intuitive and should not require training.
Broad Network Access: Cloud based services provide a broad internet access.  For instance, consider gmail.  It can be accessed through desktop, laptop, tablet, smart phone etc.  Cloud based services enable an ability to easily synchronize information over multiple devices.
Resource Pooling: Amount of traffic over the internet is rapidly growing. Because of the distributed nature of the internet, there is no single point of measurement for total internet traffic.  But it is a fact that the total global IP traffic will pass the zettabyte threshold by the end of 2015.  By the year 2017, the total internet traffic is expected to reach 5.3 zettabytes.  To put it in perspective, if the 11 oz coffee on your desk equals one gigabyte, a zettabyte will have the same volume as the great wall of China!  Cloud based services enable customers to pool their resources and save cost.

Rapid Elasticity: In the world of internet activity there are lot of peaks and valleys.  Cloud can scale based on demand peaks, without incurring penalty for the period of low traffic.
Measured Service: Cloud offers and ability to pay as you go.  People can pay for the internet infrastructure as they pay for electricity.
Some of the examples of cloud based services include, SalesForce, Netflix, Gmail and Amazon.

Clinical Data Trends

Spiraling costs have been a grave concern in healthcare.  Typically, efficiency has not been very high in the area of healthcare. Costs of clinical trials is likely to increase even more significantly, in future, on account of increasing costs of medical research and changing and tightening regulations, among other things.  Increased costs for clinical trials will push the cost of drugs higher.  On the other hand, there is strong public criticism of higher costs of medicines and there is a lot of pressure on drug companies to contain costs.  Companies have pressure to cut the middle layers and manage clinical trials on their own.  Citing CISCRP (Center for Information & Study on Clinical Research Participation) study, Gicqueau said, currently, only 6% of clinical trials are completed on time, whereas 72% run late by over a month.

Compliance issues and regulations specified in 21 CFR, part 11, prohibit use of public cloud, for clinical data.  Clinical data has to be stored in a private cloud.  Clinovo’s ClinCapture is a cost-effective EDC (electronic data capture) system.  It is tailored to specific clinical studies teams and offers intuitive navigation and one-click access to routine functions.  It reduces time for data entry.  ClinCapture is also flexible and can be customized and deployed rapidly.  “We validate our software like medical devices are validated”, said Gicqueau.

Mobile is next major trend, as more data entries are happening through tablets and smart phones.  Tables are also very useful in remote regions of the world where cell phone reception may be spotty or non existent, where information can be easily synchronized later.  Data entries can also be structured  by getting patients involved.  Data integration is another big challenge.  Everyone hopes to make sense of the data and make meaningful use of the data.  However, making sense of the data and putting it to good use remains expensive.  Gicqueau said, meaningful data integration is another promise of the cloud.

Clinovo is launching CloudClinica, next generation, cloud-based eClinical platform.  With its easy to use, pay as you go platform, CloudClinica will eliminate IT dependency and allow small companies  to manage clinical studies in a sophisticated manner, without high level programming skills.  About 30% of cost and 60% of time associated with clinical trials is about data management, and almost 80% of clinical trials are still conducted on paper, said Gicqueau.  Paper has many pitfalls.  Paper can get lost, it is inefficient, there is challenge of mis-reading someone’s handwriting, it has regulatory risks and other hidden costs.  CloudClinica is FDA compliant and it can scale.

HomeClinovo had revenues of over $4 million in 2013 and raised $500,000 from business angels over the last few months to execute on their business strategy.   The company is profitable, and has 30+ clients that include Gilead, Roche and others.  Clinovo is now targeting small to mid-size companies, said Gicqueau.  Current market of $2.3 billion can be rapidly growing in the coming years.  MediData and Oracle are two dominant players but are relatively more pricey.    Clinovo’s CloudClinica will fill in the gap and broaden the use of eClinical systems and will empower and bolster the biotech, pharmaceutical, and medical device companies, said Gicqueau.  The event was followed by Q&A.

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