Posts Tagged Software

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 – September, 2015


Please see below some of my immediate opportunities.  Post doc and contract opportunities are for candidates located in the United States.  But there are some new opportunities below that are located in India, 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.

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.  

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.

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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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.

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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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High Performance Computing Solution to Overcome Current Limitations in Mass Spectrometry


Jeff Peterson, Chairman at Veritomyx and CEO of parent company, Target Discovery, talked about how Veritomyx is focusing on convergence of high performance computing and state-of-the-art signal processing algorithms, to deal with the challenges encountered in identifying protein/isoform and metabolite biomarkers, due to limitations in mass spectrometry and supporting software.  The talk was in Sunnyvale, at event hosted by www.bio2devicegroup.org .

Modifications of proteins are responsible for exerting about 90% of the control of biochemical pathway changes. Accurate detection and validation of these changes offers hope for much stronger diagnostic insights into disease status and valuable treatment guidance decisions, enabling new effectiveness to advance the field of personalized medicine.  In turn, this is expected to help determine specific potential responses of therapeutic compounds in individual patients, allowing for more customized and successful treatment regimens.  Selection of properly validated therapies would save huge amounts of resources, money, and most importantly improve patient outcomes.

In the US, healthcare expenditure currently averages around $3T per year, said Peterson.  About 85% of that is spent on doctors, hospitals, ER, and end of life management.  Drugs make up only 12-15% of the total expenditure and diagnostics represent 2-3%.  The dawn of personalized medicine diagnostics now allows the right diagnostic to better select for the right therapeutic, and to minimize the patient’s descent into the chasm of other healthcare expenditures.  This paradigm shift is upending the value proposition in favor of newly recognized value in personalized medicine diagnostics leveraging overall healthcare expenditure decreases with improved outcomes.

A Shimadzu Ion Trap-Time of Flight mass spectr...

A Shimadzu Ion Trap-Time of Flight mass spectrometer (center), HPLC-UV (left). (Photo credit: Wikipedia)

The search to find, identify and characterize new biomarkers across life science R&D efforts typically employs mass spectrometry.  In MS, ions from the unknown are accelerated and detected electro-magnetically, and software attempts to assemble puzzles of component ions into information identifying the unknown parent.  The output is typically analyzed in the form of a diagram, with X axis reflecting the masses of the individual ions, and the Y axis showing the  “relative abundance” of the ions detected.

 

However, current limitations in mass spectrometry, signal processing and identification algorithms often limit the availability of useful information.  Frequently, critical information remains hidden among overlapping peaks.  Overlapping peaks cause misdirection in mass and abundance results, delivering lower mass and abundance precision, and making it vastly harder or completely failing to correctly identify biomarker compositions.

English: Isotopic pattern of an peptide. Mass ...

English: Isotopic pattern of an peptide. Mass spectrum recorded by Q-TOF mass spectrometer. Polski: Obwiednia izotopowa peptydu zmierzona przy pomocy spektrometru Mas Q-TOF (Photo credit: Wikipedia)

The “PeakInvestigator™” software from Veritomyx, helps enhance the quality of science, saving critical time and R&D resources.  PeakInvestigator typically triples the effective resolution and reveals and precisely deconvolves overlapping peaks that go unnoticed by current mass analyzers and software.

Precision problems in the data not only waste a great deal of time, but they can misdirect attention and decrease the effectiveness of R&D efforts.  Abundance and mass errors produce spurious biomarker candidates and incorrect isotopic ratios for peak identification, said Peterson.  The PeakInvestigator software delivers up to 10X improvements in mass and abundance precision across a wide dynamic range when deconvolving previously hidden overlapping peaks.

The PeakInvestigator is based on statistically robust and reproducible methodologies, said Peterson and it enhances identification of unknown proteins, peptides, and metabolites to improve the ability to correctly detect and validate biomarkers.  Further, it’s advanced signal processing algorithms automatically adjust for differences in instruments and tuning variations.  These algorithms provide adaptive baselining and signal-to-noise thresholding.  This easy to use software solution eliminates the need for manual estimation of centroiding parameters or visual inspection of data before processing.  When summing up the advantages, Peterson also added that PeakInvestigator is being designed to be 21CFR11 and HIPAA compliant.

For companies interested in PeakInvestigator software-as-a-service solution, it can be easily integrated into the existing workflow.  Their simple public application-programming interface (API) inserts directly into company’s existing mass spectrometry workflow.  While already validated workflow remains intact, the PeakInvestigator algorithms can be leveraged on the existing data.  Currently Veritomyx has launched Free Beta Services collaborations for its PeakInvestigator deconvolution and centroiding software.  Free Beta Services will allow collaborators to apply certain PeakInvestigator high performance computing capabilities to their own mass spectral raw datasets at no charge.   Please contact www.veritomyx.com for further information.

 

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Fiona Ma (Assemblywoman & Campaigner against Hepatitis B) to speak at Health Technology Forum Conference


Hepatitis B Virus

Hepatitis B Virus (Photo credit: AJC1)

Hepatitis B (HBV) virus is a very common virus worldwide.   Approximately, 1.2 million people in the United States are affected by this virus.  Almost 350 million people worldwide, are living with Hepatitis B.  Many people with Hepatitis B are likely to be infected at birth or in early childhood, and due to lack of immediate attention, have developed a lifelong chronic infection.   Hepatitis B is a contagious liver disease that is commonly spread through blood, semen, or other body fluids.  Most people do not experience symptoms until it is too late.  The virus causes 80% of all liver cancers, if left untreated.  Hepatitis B can be prevented with vaccination.  And with immediate attention and monitoring with nutrition, fluids, and medical supervision, acute Hep B can also be effectively treated.

Fiona Ma, incumbent democratic candidate for State Board of Equalization, a reputed politician and a former member of the San Francisco Board of Supervisors, California State Assembly, is a tireless campaigner and spokesperson for “San Francisco Hepatitis B Free” campaign.  San Francisco has the highest concentration of Hep B in the country.  Ma herself learned that she had Hep B, when she was 22.  She acquired it from her mother, who had acquired it from her mother.  About 1 in every 10 Asian Americans, is infected with the virus.  Ma’s mother had developed liver scars and having caught that early, had it removed.

English: California State Assemblywoman Fiona Ma

English: California State Assemblywoman Fiona Ma (Photo credit: Wikipedia)

Fiona Ma will be giving keynote address at Health Technology Innovation Forum annual conference on May, 20 at Parc 55, Wyndham Hotel, SF.  The conference is focused on exploring pathways to sustainable health through various means including “best practices for globally underserved”, through “gamification” and “patient engagement”, and through “building resilient communities for better outcomes”.  Traditionally, this conference is heavily attended by physicians from UCSF, as well as entrepreneurs focused on healthcare breakthroughs.  Please register for the conference at http://www.healthtechnologyforum.com , 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.

 

Please note other upcoming events below – dates & deadlines.

1) Register for #TiEcon at link https://www.123signup.com/register?id=dbnfb&ref=4182698  as my guest & enter promo code tievalue to get $100 discount. If you are an entrepreneur, I would say this is the conference, you don’t want to miss.  Check out great agenda, top notch speakers & panelists on #IoT, #bigdata, #cloud, and #Healthcare tracks at http://www.tiecon.org.

3) Feel free to send me an email for any of these events at wd_darshana at hotmail dot com and you can follow my updates on Twitter @DarshanaN.  Also, do check out (in JOBS category on this blog), my job opportunities that include many Quality Engineering jobs in CA and MA and hot Software Embedded Engineer job and more.

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JOBS – November, 2013


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 (except one for post doc) require several years of industry experience and are only for local candidates, with valid US work visa (except the first one which is located in Taiwan).  Also note, opportunities at the top are hot and the ones lower down may be at various stages of being filled.  I am awaiting more job descriptions and will keep adding.   Leads appreciated.

Director of Laboratory Operations – Taipei, Taiwan
Reports to General Manager

An early stage company revolutionizing early cancer detection and prevention, bringing a superior quality of life, has an immediate opening for Laboratory Manager/ Director in Taipei, Taiwan. With its simple, accurate, and proprietary blood test, the company’s vision is to screen every person in the world. The technology was developed by scientists from Stanford University’s Genomics Research Center in Taiwan. The company has offices in Silicon Valley (U.S.) and Taiwan, and is funded by a leading venture capital firm in the U.S. and prominent technology industrialists in Taiwan.  This position is currently located in Taiwan.

Summary:  This is a key position, required to manage and run a clinical laboratory currently being established in Taipei, Taiwan.  The position reports to General Manager.  The Director of Laboratory Operations will have sole responsibility for all aspects of running the company’s Clinical Laboratory.  S/he will plan, organize, schedule, and direct work in order to effectively maximize the Laboratory’s employees, equipment, and materials utilization within budgetary constraints while adhering to quality technical standards. This individual will provide direct on-site supervision of specimen workflow, test performance, operations, clinical report generation, quality, compliance, and associated documentation to adhere to company policies and procedures and Taiwan Ministry of Health and Welfare Regulations.

Responsibilities: Manage the day-to-day operations; Ensure all lab policies & procedures meet the standards of current applicable lab regulations in Taiwan, & ensure compliance through documentation, audits, & corrective action; Develop & implement plans for initial lab set up, expansion to accommodate growing volume, & for validating new tests.  Perform and/or delegate the scheduling, planning, staffing, and monitoring of workflow to meet established goals; Maintain adequate staffing by interviewing, hiring, training, and assessment of personnel; Provide staff development through performance development and review; Support, implement, and ensure compliance with all company policies and procedures.  Direct updates of laboratory standard operating procedures and databases to accurately reflect the current practices; Procure appropriate supplies and equipment to maximize efficiencies and to meet established budgetary and quality goals; Maintain equipment and instruments in good operating condition, recognizing any malfunctions and troubleshooting as needed; Provide technical oversight and serve as a technical supervisor for problem solving and process improvements in order to ensure accurate test performance and to maintain adequate workflow; Work as needed with Research and Development on new projects and for technology transfer; Monitor and ensure implementation of goals to meet established quality assurance, quality control, and quality improvement plans; Ability and willingness to follow all laboratory procedures; Ability and willingness to act in accordance with regulatory compliance requirements, including but not limited to company’s quality system requirements

Qualifications and Experience Required:  Registered Medical Technologist in Taiwan.  10+ years of experience as a Medical Technologist or equivalent in a clinical laboratory environment, including supervisory/management function; BS/BA degree in Medical Technology or related field; Word processing, statistical/data management skills required; Must have proven leadership and interpersonal skills. Excellent oral and written communication skills required. Fluency in Mandarin and working knowledge of English; Familiarity with Taiwan Ministry of Health and Welfare Regulations, patient privacy protection regulations, and ISO 13485 requirements; Familiarity with ISO 15189 and 17025 desirable.

QA Testing Manager – Mountain View, CA

There is an immediate opening for QA Test Manager at remote health startup that is focused on bringing diagnostics into home use, with a vision to change healthcare.

Responsibilities: Define and manage validation and verification processes for medical devices; Analyze validation & verification needs, determines effective strategies & resources, & implement needed processes; Ensure that all work adheres to applicable SOPs, standards & regulations; Take responsibility for forming & maintaining the V&V team and directing the preparation & execution of all work.  Requirements: Bachelor’s Degree in a technical field, Biomedical Engineering, Electrical Engineering, Computer Engineering or Computer Science preferred; At least 3 years experience testing against product requirements and tracing tests to product requirements; At least 3 year experience working with design engineers, software, electrical and mechanical engineers and external and internal customers; Experience in working with engineers to design for testability; Experience managing short-term or outsourced testing resources on-site or off-site; Possess requirements & technical documentation preparation & analysis skills; Strong communication, analytical & interpersonal skills.  Preferred: Master’s Degree: Biomedical Engineering, Electrical Engineering, Computer Engineering or Computer Science preferred.; Expert in creating, managing, and executing test plans, procedures, and scripts; Expert in manual, automatic, regression, blackbox, whitebox, boundary condition, performance and other standard testing methods; Experience working with manufacturing team; Experience using a requirements and test management software system; Experience in leading a V&V team.

Director Quality Engineering – San Jose, CA

There is an exciting opportunity for Director 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 tomap 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.

Head of Molecular Analysis – Mountain View, CA

An early stage, recently funded company with revolutionizing early cancer detection and prevention technology, comprising of simple, accurate, and proprietary blood test, has an immediate opening for Head of Molecular Analysis.  This is a critical, highly visible position and requires minimum 8-10 years experience in both hands-on analysis and strategic experience to build the team.  There will be equity sharing in addition to competitive salary.  Will require frequent travel to Taiwan and ability to speak Mandarin is a huge plus.

The successful candidate will lead, design and implement the overall molecular analytical approach to be adopted by the company for early cancer detection through the use of “rare cell” technologies. Working with the R&D team in Taiwan, s/he will design and build the molecular assay platform and panels for identifying major types of cancer. In addition, this person will lead the effort to productize the molecular fingerprinting panels so that they can be offered for sale commercially worldwide. Being in a fast moving start up environment, the candidate is expected to be hands-on as well as capable of building and managing a team over time.

Responsibilities Develop and maintain a map of suitability characteristics of molecular techniques to identify / confirm cancers through rare cells isolated by the company platform; Develop & implement a plan to build a molecular assay platform to identify major cancer types; Productize developed “rare cell fingerprinting panels” for specific cancer types per the company’s product road map; Advise and assist on optimizing existing & new assays for stability, specificity, sensitivity & reproducibility, following the principles of design control; Setup & manage a molecular lab in the US to supplement/complement the Taiwan lab; Evaluate the feasibility of ctDNA (circulating tumor DNA) & if applicable develop a ctDNA assay; Evaluate & make recommendations on the costs/ benefits of commercializing alternative techniques; Monitor & ensure implementation of goals to meet established quality assurance, quality control & quality improvement plans; Act in accordance with regulatory compliance requirements, including but not limited to company’s quality system requirements; Represent the company at major annual conferences through publications & speaker panels; Work cross functionally to patent innovations worldwide.

Skills & Experience:  Ph.D. or equivalent degree in Cell or Molecular Biology, Biochemistry, Immunology or other biomedical science with 5 – 10 years of relevant industrial experience; Generation, isolation & sub cloning of nucleic acids from genomic, mRNA & recombinant sources through PCR, restriction digestion, ligation, transformation & transfection or other techniques; In-depth knowledge & expertise in developing automated molecular assays or methods, including real-time PCR, next generation sequencing, or others; Skills in optimizing assay design & condition, including Design of Experiments (DOE) optimization where appropriate; Familiarity with “rare cell” technologies for cancer detection and screening including CTCs, cell free DNA and other cancer markers, desirable but not required; Have an in-depth understanding of the research laboratory environment and be familiar with complex laboratory equipment / instrumentation, including working experience with perishable samples such as human blood; The candidate should demonstrate a track record of creativity and innovation in hypothesis building and experimental design to deliver definitive results; Record of significant contribution to publications in peer reviewed journals and presentations at scientific meetings; Proficiency in conducting studies under design control, and in technical writing for study protocols, data summaries and technical reports, suitable for submission to regulatory agencies; A team player with excellent oral and written communication skills; Capable of adjusting to a dynamic start-up working environment and changing priorities; Working knowledge of data analysis and interpretation, and statistical analysis; Willing to travel to Taiwan.

Director of R&D/ Mechanical Engineering – San Jose, CA

There is an immediate opening for Director of R&D Mechanical Engineering in an early stage company developing a novel approach for the oral delivery of large drug molecules.  This position is responsible for effectively leading multi-project R&D efforts of the organization through technical expertise, interpersonal skills & a clear vision for execution.

Responsibilities: Manage resources to accomplish multi-project product research & development; Provide Mechanical Engineering support to meet R&D objectives; Remain current on developments in field(s) of expertise and industry trends; Actively pursue development of corporate IP; Identify future product opportunities; Develop plans & analyses for execution and review with leadership team; Maintain & update appropriate controlled documentation; Mentor junior staff members.

Skills & Experience: Demonstrated leadership of technical teams in medical device field; aptitude for & mastery of Mechanical Engineering principles; problem solving skills in a multidisciplinary environment; Proficient with statistical analysis for engineering and manufacturing; ability to work closely with team members across engineering & non-engineering disciplines such as biochemistry, physiology, pharmacology & chemistry; Knowledge of plastic manufacturing processes including injection molding, thermoforming, casting, machining, extrusion etc.; Knowledge of metals & alloys used in medical devices and processing techniques such as brazing, laser welding & cutting, electropolishing, electroplating, machining etc.; Deep experience in polymer processing, catheter design & fabrication, including knowledge of polymer joining, fusing, die cutting, adhesives etc.; Knowledge of biomaterials & coatings suitable for implantation; Knowledge of packaging & sterilization techniques; ability to interface effectively with professionals in the medical and biological sciences; knowledge of sound design principles, regulatory requirements, and product and process validation procedures; proficiency with computer aided design software & hardware. Formal training on systems & software is desired.

Also required: Bachelor’s degree or higher in Mechanical Engineering; 10+ years experience in engineering and product development with demonstrated capability & thorough understanding of the medical device product development process; Three years minimum direct personnel management & related project leadership experience; ability to map task interdependencies, multi-task, prioritize such tasks, meet deadlines & develop, monitor and live within budgets as well as ability to forecast major milestones. Must be skilled at delegation, follow-up, and team building.

Research Engineer – San Francisco, CA

A company working on highly advanced and innovative consumer health sensing technology, has an immediate opening for Research Engineer in San Francisco, CA.  Responsibilities include, research, implement, and analyze cutting edge physiological sensors and signal applications, help design and trouble shoot experiments for top secret projects pertaining to future product offerings, and work closely with excellent research and device team to ingrate the work into amazing consumer products.  Requirements include, Bachelors in Engineering plus 2 years experience or MS in Engineering, proficiency sensors, signal processing, and exploratory data analysis.  DSP techniques including time series analysis, adaptive filters, and noise cancellation, demonstrated ability in a scientific computing language (R, Python, and/or Matlab), and passion for health, wellbeing, and fitness are great plusses.  An advanced degree, Knowledge of NoSQL database systems, biomedical engineering background, prior experience in physiological sensors, real time biological data processing, Electrical Engineering, etc. are huge pluses.   This is a contract to hire opportunity, for local residents only (no visa processing).  The opportunity will start as full time contract opportunity and will turn into permanent opportunity in a period of 3-6 months.  Compensation will be between $30 and $45 an hour and will include stock options, as added incentive.

General Manager – Software Engineering, Life Sciences – CA

There is an immediate opening for General Manager of Software Engineering in Life Sciences Division, with a large company near Dublin, CA, with a broad portfolio of transformational medical technologies in medical imaging & information technologies, medical diagnostics, patient monitoring and life support systems, disease research, drug discovery, &  biopharmaceutical manufacturing technologies. The focus is in helping physicians detect disease earlier and to tailor personalized treatments for patients, & improving productivity in healthcare and enhance patient care by enabling healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases, & other conditions.

Job Description
The GM for Life Science Software Engineering is a key member in the Chief Technology Officer’s Executive Leadership team. The position requires excellent technical and operational knowledge coupled with superior people leadership skills, program management experience and business planning processes. The GM, Software Engineering will: Provide advanced technical expertise and thought leadership in the area of strategic software development and governance; Lead and drive next generation product software strategies and services. With strong leadership and close collaboration with functional business leaders ensure Life Sciences software architecture is set to meet the needs of the future; Align strongly with and leverage the San Ramon software center of excellence; Drive business innovation and transformation with strong platform leadership. Move away from point solutions towards effective processes and tools, creating a change-enabled architecture platform, enabling flexibility and agility in the business; Maximize the value of each SW/IT investment Lif Science division. Focus on not just solving and solution for today’s projects, but solving for tomorrows needs by building the longer term plans (architecture blueprints and roadmaps) and driving projects to align to the longer strategic plans. Adapt HC SW solutions and COE architecture wherever efficient and applicable in a lean fashion; Drive efficiency to Maximizing the reuse and Simplification. The future Architecture must ensure that we drive towards a more standardized and reuse based SW development; Drive implementation of processes and tools for efficient and effective global software development lifecycle; Drive Life sciences wide software governance to ensure goals and targets are met and are measurable. Lead the Life Sciences review processes for software architecture; Integrate internal and external product design into a cohesive world class user experience; lead and direct activities within the Life Sciences business software area including reference application architecture; content models design patterns; service-based architecture strategy, development and support and other areas; Be responsible for program budgets and/or cost centers, resource allocation and planning to ensure delivery of business benefits.

Desired Skills & Experience
Minimum Qualifications: Bachelor’s degree CS/MIS or similarly positioned technical discipline; Minimum twelve years IT experience; At least eight years of leadership experience leading large design efforts and coordinating project for reputed multinational IT organizations; At least five years as a manager of geographically distributed development teams with 10 or more members.

Preferred Qualifications: Masters in Computer Science or similar discipline; Experience with a broad array of Infrastructure technologies (compute, network, telecom, database, etc.); Demonstrated program management skills including project initiation, scoping, resourcing, scheduling, budgeting, risk management and communication ; Project management experience in global environments; Excellent interpersonal, presentation and facilitation skills; Ability to learn complex systems and business processes and define requirements for solutions; Mastery of user interaction design skills; Familiarity with field and lab-based usability research methodologies; Ability to communicate design rationale and build consensus; Ability to prioritize and manage work to critical project timelines in a fast-paced environment; Previous experience in medical devices; Expert understanding of regulatory requirements, IT SOPs and Validation SOPs; Experience working in Agile Environment.

Post-Doc ———- San Jose, CA

A medical device company has a post-doc position.  Requires PhD in Material Science, BioEngineering, BioChemistry or related areas, ideally from a top notch school.  Must have excellent references.  Send resume as an attachment with brief description of the academic experience and projects, in the body of the email.

Patent Attorney – Sunnyvale, CA

Innovative medical device company with a broad line of product portfolio, has an opening for Senior Patent Attorney for VP level position.  Must have 15+ years of medical device and biotech patent prosecution experience in a law firm.

Manufacturing Manager – Santa Cruz, CA

Job Functions & Responsibilities: This position will be responsible for managing production operations to ensure business objectives are achieved at the lowest cost consistent with customer delivery and quality requirements.  Responsibilities include: Manufacturing scheduling and staffing; Production methods and standards; In-process product quality; Materials responsibilities including procurement and inventory management; Safety policies and procedures; Hourly employee development, performance management and relations; Continuous improvement and Lean Manufacturing Leadership and implementation; Budget management and cost containment.

Requirements: Knowledge of Manufacturing concepts and principles; Experience in Lean Manufacturing, Process management/statistical process control, Production layout/design/method, Manufacturing equipment management and knowledge of Business and office system software.  Also required, experience in Capacity planning; Scheduling/MRP; Budget management; Team development of both hourly and salaried direct reports; Problem analysis/solving; Managing internal and external relationships.  Bachelors degree or equivalent experience required.  Also required, Medical/Cleanroom/Assembly experience; Experience managing a 24/7 operation; Ten years manufacturing experience; Management experience; Experience in the Injection Molding/Plastics industry.

Accountability measures include, Quality, Safety, Productivity, Utilization, Service, Deliver, Cost efficiency and continuous improvement, and Employee development and retention.

Software Developers – SF Bay Area (contract, part-time)

Big data and machines are revolutionizing the way we operate. A software company that provides innovative, modular, scalable and world class solutions, in this industrial-internet paradigm, by leveraging state of the art sensor technologies, cloud computing, big data analytics, and complex event processing, is now scaling in pre-funding stage. Some of the clients include Cisco Systems, Applied Mateirals, Huawei, Agilent, HP, Foxconn, Fletronics, and Sanmina that are using this software to transform their engineering and manufacturing operations. The company is expanding core engineering and product development team and looking for high caliber, senior software developers, with interest in working with cutting edge technologies in a high energy entrepreneurial environment.

Responsibilities include: Being involved in all stages of SDLC including analysis, design, implementation, testing, documentation, and release; Participate in multiple projects with changing requirements; and Maintain contact with clients/ partners to provide solution support and updates.

Requirements include: 4-6 years of software development experience; Software Development experience; ASP.NET with MVC, JQuery; Comfortable in data modeling, developing stored procedures, and triggers; and Readiness to learn new technologies quickly. Windows Workflow Communication Foundation 4.0; Biztalk RFID server skills; Windows Mobile Development experience; and Exposure to Windows Azure.

The position is located in the San Francisco Bay Area. Telecommute is okay but may need to attend client team meetings. Duration: 6-12 months to full-time. Terms: 1099, corp-to-corp, contract-to-hire, no visa sponsorships. Pay: rate negotiable. Open to considering excellent part-time candidates.

JOB Toulouse

JOB Toulouse (Photo credit: JiPs☆STiCk)

 

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Jobs – January, 2013


Guidewire ClaimCenter Professional –  (location – Washington DC).

This is a one year contract opportunity.

SOA Engineer Lead Role – Tampa, FL – 1 year duration

There is an immediate opening at Tampa, Florida location for SOA Engineer for 1 year duration contract work.

Skills required: Very strong knowledge in WebLogic 10.x/11g and FMW space, Strong knowledge Oracle SOA10g/11g & OSB11g implementation/administration, Experience with all out of box technology adapters (Apps, DB, MQ, JMS, File, FTP, etc.) and configuration, Experience with Oracle OAS10g, BPEL, OHS, OWSM, SSL strategies, Linux, Unix, Windows Server, AS400, z/OS, Oracle OEM11g/12c, IBM Tivoli, Subversion, SQL, Visio, Oracle SOA/ESB development skills a plus but not required, Scripting knowledge (WLST, ANT), JVM monitoring/tuning experience, Performance monitoring and tuning, Strong communication skills.

Job responsibilities include: Architecture planning and design for all related components, Evaluate project proposals and estimated related labor to implement, Installation and configuration for environment builds including post build expansion, Product patching and analysis for implementation, Capacity planning and scaling analysis for all components, Create and maintain documentation as needed for future reference, support turnover, etc., Present topics of interest for team knowledge and review related to ongoing initiatives, Participate in knowledge transfer for level 1/2 support teams, Performance monitoring and identification of related issues, Manage engineering service requests and defects, Support code migration, automation and troubleshooting, Engage with other IT tech teams and request systems for troubleshooting or infrastructure dependencies related to project task completion, Provide guidance for Level1/2 teams as relates to their assigned tasks, Initiate, communicate and drive production changes via formal change management system, Take ownership of assignments and drive them to conclusion, Initiate vendor support requests and keep momentum for conclusion, Implement monitoring solutions as needed for existing or new components, Implement automation solutions for repetitive tasks where appropriate, Participate in 7×24 on-call rotation support for production.

Oracle SOA Architect – Herndon, VA, – 1 year Duration 

There is an immediate opportunity for Oracle SOA Architect at Herndon, VA for 1 year duration contract job.

Skills & experience required: Min 10 years of experience in Software Design/Development, Project experience in designing and implementing Oracle SOA suite components, Experience in the design/ implementation of technology infrastructure and architecture blueprint including Oracle Fusion Middleware, Must have experience as an SOA Architect /Tech Lead in delivering at least two SOA Enterprise-level Projects including at least one involving legacy mainframe systems, Hands on experience in SOA analysis/planning, Service Modeling, Business Process design, SOA Composition, SOA Governance etc., Strong Java/JEE development experience, specifically in regards to deploying applications, leveraging AIA patterns and experience in architecting SOA-based solutions, Proven project experience with hands-on development and configuration experience in Oracle JDeveloper 11g with strong BPEL design/development skills, Technical know-how on and hands on experience in designing a SOA governance framework using Oracle SOA products, Excellent written and verbal communications skills, Experience with UML. Knowledge of design patterns.

Required Tech skills: OSB (Oracle Service Bus ), Oracle Mediator, BPEL Process Manager, Oracle BPM(Business Process Manager), Oracle CEP (Complex Event Processing), Oracle Policy Manager, Metadata Service Repository, Oracle Business Activity Monitoring, OEM (Oracle Enterprise Manager), Oracle Adapters, Oracle Business Rules, Oracle User Messaging Service, JDeveloper , Java, J2EE, Web Services , SOA, REST , XML /XPath / XQuery / XSLT, Any recent versions of Oracle Database.

Seeburger Architect – Hartford, CT, 1 year duration

There is an immediate opportunity for Seeburger Architect for 1 year duration at Hartford, CT location.

Skills & requirements include: Should have architecture and design experience, Should know the pros and cons of various B2B products vs Seeburger BIS 6 and BIC 6, Should have work experience in BIS6 and migration, Should be well aware of communication protocols and transaction standards, Should have worked in Business process implementation and testing using BIS6 process designer, TP setup and mapping experience using BIC6 Mapping designer, Should have good communication skills, Should have onsite –offshore and SDLC work experience.

Analog Design Engineer –  Sunnyvale, CA

A Contract Engineering company located in Sunnyvale, CA has an immediate part-time contract opportunity for Analog Design Engineer, that is likely to become permanent in 3-6 months. Minimum 10 years of experience with analog circuit design, including amplifiers, ADCs, power supplies, and sensor signal conditioning is required. Also required, experience with digital design and ability to work with digital engineers to develop successful integrated products. Experience with signal integrity and/or RF design a plus.

The person must work well on a team, have good communication skills, and be able to adjust quickly in a fast paced environment where many designs are done simultaneously. This is a challenging and rewarding opportunity for the right person.

Clinical Data Manager – Redwood City, CA

There is an immediate opening for Clinical Data Manager for San Carlos, CA based medical device company. Responsibilities include, design, develop and enhance clinical databases and data reports and perform validation of databases and reports to ensure data accuracy, completeness and integrity of data entry, discrepancy database management, study documentation and data auditing. Job functions include, participating and providing support for data management activities, investigator meetings, DSMB meetings and regulatory submissions, assisting study team with the preparation of data collection forms and charts for the reporting of research data, supporting international and FDA regulations and company goals, policies and procedures, and complying with Quality System.

Requirements include, knowledge in regulatory requirements, FDA, ICH, GCP etc. guidance, experience using Commercial Off the Shelf Clinical Data Management and/or Electronic Data Capture products (e.g. Clindex, Oracle Clinical, Phase Forward, eTrials, etc.) is required. Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) is a plus. Also required, a Bachelor’s degree in related field with minimum 3 years experience in clinical data management supporting clinical trials, including experience in regulatory submission of drugs or medical devices.

Sales Rep – Los Angeles, CA

This position will play a visible role in drug rep industry, by developing critical relationships, primarily with doctors of many disciplines to share the availability of breakthrough pharmaceutical grade pain management option that would diminish pain, aid in sleep, and enhance quality of life as a holistic alternative to addictive and sometimes life threatening drugs. Specific responsibilities will include, provide field based scientific exchange and communication regarding the product, broad interdisciplinary background and proven ability to establish relationships with doctors across variety of disciplines, tenacity and drive to reach out to new doctors, and ability to work the referrals, and to network and partner with medical practitioners. Requirements include, pharma or medical industry sales background, strong sales success track record, consummate professionalism including understanding of sensitivity of subject along with ability to deal warmly with high powered, industry-leading medical professionals, strong entrepreneurial spirit and passion for the vision of managing pain with a holistic alternative. This position is located in Los Angeles, CA.

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JOBS – May, 2012


For the opportunities below, please send resume to wd_darshana at hotmail dot com.

IT Project Manager (Contract Opportunity) – Bay Area, CA

There is contract opportunity for IT Project Manager with a Biotech company.  The start date for the contract is July, 1 and the project is expected to last 9-12 months.  The candidate is expected to have 10-15 years of experience in Project Management.  Job responsibilities include, plan, execute, and finalize projects according to strict deadlines and within budget, acquiring resources and coordinate the efforts of team members and third-party contractors or consultants in order to deliver projects according to plan. Responsibilities also include, define project scope, goals and deliverables to develop full-scale project plans, liaise with project stakeholders on an ongoing basis, supervise project team members, identify and resolve issues and conflicts within the project team, proactively manage changes in project scope, and identify potential crises.  The immediate projects include implementing company laptop encryption system, learning management system validation, and completion of proof of concept deliverables pertaining to data mapping and data migration between HR Master and AWR and Exterro.

Junior Software Embedded Engineer – Sunnyvale, CA

There is an immediate opportunity for Junior Embedded Engineer in $60-$80K salary range with a reputed contract engineering company, located inSunnyvale,CA.  This position requires an understanding of both hardware and software and how each can influence the other at all levels of the design process.  This opportunity offers a chance to work on a wide range of fun and interesting projects and an opportunity to work with and be mentored by a world class team of staff and consultants.  Requirements include MSEE + 1-2 years experience or BSEE + 2-3 years experience, keen interested in embedded systems and some experience with a number of current processor architectures, e.g. PIC, MSP430, ARM.  Also required, an ability to program embedded systems in C, C++ or other languages, knowledge of assembly language,  knowledge of test equipment such as oscilloscopes, logic analyzers etc and how to use them, experience with schematic capture, along with the ability to build simple prototype electronic circuits, and ability and skill to interpret customer requirements into design ideas and the knowledge and confidence to take those forward into a working solution with the assistance of other members of staff.

Quality Engineer – San Jose, CA

Drug delivery company has an immediate opening for Senior Quality Engineer with 10+ years pharmaceutical industry experience in sterile manufacturing and process qualifications for injectible drugs. Experience in documentation and batch process and automation quality systems setup and management experience is required. Qualifications should include BS in Chemical Engineer, Mechanical Engineering or related. This is a grounds level opportunity to work on game changing technology with solid IP and secure funding, under the leadership veteran leader with several successful companies. Compensation will be commensurate with experience and will include stock options, with great potential.

Injection Molding Machine Building & Manufacturing Engineer – San Jose, CA

The ideal candidate for this job will be an expert in injection molding with 10+ years of deep experience.  Experience working with suppliers is not enough.  Experience with tool design and mold machine building is required.  Also required, mold design, AND operating, and fabricating of injection molding machines.  Working knowledge of design/development of manufacturing systems with emphasis on new molds and molding processes, creating and understanding mold flow analysis and ability to implement installations or modifications of new equipment and/or machinery to support the injection molding processes is required.  Hands on experience in the tooling part of plastic injection molding, taking apart and adjusting molds on a daily basis will be called upon.  Experience in Autocad and SolidWorks and BS in Mechanical Engineering is required.  Experience in vacuum forming, a huge plus. This is a grounds level opportunity to work on game changing technology with solid IP and secure funding, under the leadership veteran leader with several successful companies. Compensation will be commensurate with experience and will include stock options, with great potential.

PS – this is a very specialized opportunity and requires mold machine building experience to work on the first prototype that the CEO has built for very customized medical application.

Clinical Project Manager

The position will support US and OUS clinical trials in a cross-functional role to support the clinical study team.

Essential functions include manage clinical trial operations with a specific focus on European feasibility investigations, establish and maintain study master files, work with sites to prepare submissions, secure study documentation, and negotiate contracts, manage case report form data and monitoring activities, develop and refine clinical trial procedures, create and prepare materials for Investigator, Coordinator, and DSMB meetings, prepare Case Report Forms, support field clinical staff with significant involvement in site assessments, monitoring activities, site audits, and site closures as needed, write and file Adverse Event reports, annual reports, and other communications with Ethics Committees, Competent Authorities, and Institutional Review Boards, perform clinical data entry, report generation, work with sites to resolve data queries, support investigators with publication activities, as needed, provide regulatory support for US and OUS clinical submissions, interface with Regulatory Affairs department to provide support for ongoing regulatory activities, provide support for new and ongoing regulatory submissions, provide support for Product Development and Operations, development, writing of Manuals and training materials, and participate in clinical validation and product development verification activities

BS in life sciences or equivalent with a minimum of 5 years related experience in supporting medical device clinical trials is required. Experience working directly with US and EU sites and working with clinical data and database experience, strongly desired. Familiarity with literature searches, experience monitoring sites, and scientific writing skills, preferred. About 10% travel will be required.

Machinist – San Antonio, TX

Innovative medical device/ biotech in Texas has an immediate opening for Machinist. The company is found by a veteran leader with number of prior successes and this is an opportunity to contribute at grounds level, in a promising startup. (Stock options could make this a once in a lifetime kind of an opportunity). The mechanical engineer/ technician will work with other engineers to develop innovative drug delivery systems. The candidate must be familiar with fabricating small parts or tooling on a lathe and mill. Successful candidate will have combination of mechanical and electrical skills. At least 5 years experience in medical device industry is required.

Pharmacologist with In-Vivo Experience: San Antonio, TX

A dynamic company, found by a veteran leader of several successful startups, involved in the development of drug-device combination products for treating chronic diseases, has an opening for a Biologist. This is once in a lifetime kind of an opportunity to work on exciting technology with game changing potential. The applicant must have a BS with a minimum of 8 years (or MS with at least 6 years) of hands-on laboratory experience. The individual is expected to have a breadth of experience in in-vitro and in-vivo biological research supporting various drug/ device development programs across multiple therapeutic areas including CNS, oncology, cardiovascular and metabolic diseases.

The applicant will support and work with external institutions including CROs and academic institutions especially for conducting in vivo studies in small as well as large animals. Additionally the applicant will set up and run a variety of routine in vitro research paradigms as needed such as isolated tissue and cell-based assays as well as quantitative assays for small molecules, peptides and proteins using techniques such as FTIR, HPLC, and immunoassay. The applicant will work with a multidisciplinary team of experts and provide biology support with minimal supervision on various ongoing projects. The position requires a strong background in cell biology, chemistry, biochemistry, immunology, physiology or a related area. Position, salary and benefits are commensurate with experience.

Ultra Low Power Analog Design Engineer – San Jose, CA

There is an opening in CA & TX for ultra low power analog design engineer for a company found by a veteran leader of several successful companies. This is an exciting opportunity to work on cutting edge technology, with a great promise. Compensation will be commensurate with experience, in addition to the stock options. The stock options could make this highly attractive opportunity. The position requires 6+ years of experience with medical device low power analog circuit design and embedded design experience.

My colleague is working on the opportunities below. If you have an interest, please mention the opportunity in the subject line, with your name and send your resume and I will forward it to him.

Director of Clinical – San Jose, CA

VP of RA/QA – Redwood City, CA

Senior Manager of RA/QA – San Francisco, Ca

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Jobs – February, 2012


For the opportunities below, please send resume to wd_darshana@hotmail.com.

Sales – Mountain View, CA

There is an immediate opening for a sales individual  with 10+ years experience in selling regulatory compliance, project management and IT in the regulatory arena in LifeSciences (Biotech, Pharma, Medical Devices, CRO) and Genomic Companies.  Experience should be in compliance consulting, not clinical consulting.  Responsibilities include both sourcing new leads and closing deals.  Commission will be purely commission based for first 3 months and will include salary plus commission after that.  This is an opportunity to work with a veteran CEO and will include stock options.

Analog Design Engineer – Sunnyvale, CA – V

There is an opening for an analog design engineer with 5+ years experience with instruments, sensor interfaces, amplifiers, ADCs, DACs, power supplies, and motor control.  The right individual should also have broader experience in either digital design or software.  Experience in medical device industry, a huge plus.

Mechanical Engineer – Sunnyvale, CA – AM

Medical Device company working on cutting edge technology has an opening for Mechanical Engineer with 5+ years experience.  Experience with SolidWorks absolutely required.  Medical Device experience with catheter development, a huge plus.

Software Developer – Sunnyvale, CA – AM

There is an immediate opening for Windows Systems Developer who has experience with Microsoft Techologies and DotNet.  Responsibilities include, develop DotNet code using product technology architecture and frame works, perform Research and Development on newest technical components and make recommendations such as report engine, UI frame work, security, open-source components and Open Standards/ frame works like SPML, JAAS etc.  This position is with a medical device company working on cutting edge technology and offers great growth potential.  BS in Computer Science or related area plus 3-5 years experience is required.  BS in Electrical Engineering is a huge plus.

Electrical Engineer – Sunnyvale, CA

There is an immediate opening for highly motivated, self-driven Electrical Engineer for a medical device company focusing on cutting edge diagnostic technology for early detection of certain kinds of cancers.   BS in Electrical Engineering plus 5+ years experience is required.  Also required, knowledge of digital circuitry including embedded microcontrollers, analog to digital converters, and design of FPGA modules.  Project Management experience, a huge plus.

Mechanical Engineering Technician – San Antonio, TX

Innovative medical device/ biotech in Texas has an immediate opening for Machinist.  The company is found by a veteran leader with number of prior successes and this is an opportunity to contribute at grounds level, in a promising startup.  (Stock options could make this a once in a lifetime kind of an opportunity).  The mechanical engineer/ technician will work with other engineers to develop innovative drug delivery systems.  The candidate must be familiar with fabricating small parts or tooling on a lathe and mill.  Successful candidate will have combination of mechanical and electrical skills. At least 5 years experience in medical device industry is required.

Analog Design Engineer – San Jose, CA

There is an opening for analog design engineer for a company found by a veteran leader of several successful companies. This is an exciting opportunity to work on cutting edge technology, with a great promise.  Compensation will be commensurate with experience, in addition to the stock options.  The stock options could make this highly attractive opportunity. The position requires 6+ years of experience with medical device low power analog circuit design and embedded design experience.

LabVIEW & Teststand SW Developer – San Jose, CA

The opportunity below is with a company specializing in providing testing services.  Friendly company environment includes latest fully-featured tools and offers competitive salary and full benefits, including 401K matching after 1 year.

Requirements include, 3+ years LabVIEW and TestStand work preferably on production test applications, proven debug & problems solving skills, BSCS or similar degree, and 10-15% ability to travel globally.  Embedded software engineering experience (C/C++) desirable and National Instruments LabVIEW and/or TestStand certification and RF experience, huge pluses.

Senior Test Engineer: San Jose, CA 

The opportunity below is with a company specializing in providing testing services.  Friendly company environment includes latest fully-featured tools and offers competitive salary and full benefits, including 401K matching after 1 year.

Job functions include, design, build, and deploy automated production test stations, create test systems to perform functional tests, perform system integration hardware tasks, develop TestStand and LabVIEW software apps to automate test stations, work with suppliers to develop test features, debug, troubleshoot, & verify test systems, document hardware and software, and install the test system at the customer’s site or manufacturing facility.   Requirements include, 5+ years experience creating functional test systems, proficiency in developing LabVIEW and TestStand software applications, experience working with suppliers to develop test fixtures and interconnects, solid understanding of electrical circuits with good troubleshooting skills, expertise using test equipment including National Instruments hardware, and BSEE, BSCS or similar.  National Instruments LabVIEW and/or TestStand certification and RF experience, huge pluse

Physicist  – San Jose, CA – GT

There is an immediate opening for a physicist with electrophysiology background.  This person will have expertise in the propagation of low frequency electrical signals in the body from their source to the surface and onward to the coupling of electrodes.   This is a pre-revenue phase company and compensation will include equity based arrangement.  It could be a part-time or after hours opportunity for the right individual.

Modeling Expert – San Jose, CA

There is an immediate opening for Modeling Expert to set up computer simulations of the signal propagation through the body, from their source to the skin and into electrodes, using simulation packages such as Comsol Multiphysics or electromagnetic simulation programs that can incorporate biologic materials.  This person should be familiar with low frequency and DC electromagnetic modeling an comfortable with doing so with biologic materials.   This is a pre-revenue phase company and compensation will include equity based arrangement.  It could be a part-time or after hours opportunity for the right individual.

Opportunities in India

For opportunities in Mechanical Engineering and Test Engineering for Medical Device Company inBangaluru,India, see earlier job posts or send me an email.

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