Posts Tagged Clinical

JOBS: September, 2019


Good deal. Close-up of two business people shaking hands while sitting at the working place

Please see some of my current opportunities below. All opportunities are for local (US based) candidates with valid work visa and require deep industry experience.  If you have an interest then please send an email (resume as an attachment) at wd under score darshana at hot mail or find me on Linkedin.

Clinical Trial Manager – San Jose, CA

Ideal experience: 8+ years experience in medical devices, ideally in neuromodulation.  Required, experience running clinical trials, and working with clinicians and medical centers.

Head of Regulatory – San Jose, CA 

Candidate must have 15+ years experience in bio/pharma industry. Experience working with biologics and taking a drug to market in the US and EU is essential.

Mechanical Engineer – San Jose, CA

The Mechanical Engineer is responsible for evaluating the current manufacturing processes and making design improvements to increase throughput, quality and reliability. This will be achieved by redesigning the current tooling and/or creating new tooling and equipment. The successful candidate will work independently and use sound judgment to deliver optimal manufacturing solutions. This is a hands-on position that requires interaction and collaboration with a cross-functional team.

Responsibilities

· Evaluate the current manufacturing processes /workflows and identify opportunities to realize improved product consistency and increased throughput
· Develop concepts and ideas for improving the exiting tooling as well as creating new tooling including semi-automation where applicable
· Take full ownership of tooling /fixture designs, conduct concept reviews, show proof of concept through prototyping coupled with supporting test data, coordinate with appropriate stakeholders for successful verification /validation, launch and documentation
· Create 3D models, engineering drawings and bills of materials
· Create comprehensive work instructions and manufacturing SOP’s
· Work closely with Process Engineering through the creation of verification /validation protocols (IQ,OQ,PQ) as well as successful execution, data generation, report and documentation
· Establish working relationship with outside vendors, machine shops, contract manufacturers and manage the work accordingly
· Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Qualifications
· Bachelor’s Degree in Mechanical, Manufacturing or related engineering fields
· 5-7 years hands-on experience in a manufacturing environment
· In-depth experience with complex mechanical /electromechanical design
· Extensive experience with precision mechanisms, pneumatics, fixtures /tooling and mechanical components such as motors, belts/pulleys, gears, actuators, sensors, etc.
· Experience with creating engineering drawings, BOMs and product specifications
· Deep knowledge of material properties, heat treatment and surface finish
· Good understanding of DFM and lean manufacturing
· Excellent verbal, written, presentation and interpersonal skills
· Strong analytical and problem-solving skills
· Knowledge and/or hands-on experience with machine shop tools
· Deep knowledge of GD&T as well as proficiency with SolidWorks
· Prior experience with FDA regulations and ISO, cGMP, QMS standards
· Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks

Preferred Qualifications
· Knowledge /experience with electrical /electronics and PLC programming a big plus
· Knowledge /experience with plastic injection molding
· Experience with metal stamping, laser cutting and chemical etching
· Familiarity with cleaning and sterilization processes

Sr. Molding Engineer

Job Summary

The Sr. Molding Engineer is responsible for evaluating the current molding processes and leading the effort to increase throughput, quality and reliability. This will be achieved by redesigning the current tooling, creating new tooling /equipment as well as leveraging outside molding expertise. The successful candidate will become the resident expert in the areas of plastic injection molding and material selection. This is a hands-on position that requires interaction and collaboration with a cross-functional team.

Responsibilities

· Evaluate /characterize the current molding processes and identify areas of improvement while focusing on rapid manufacturing scale-up
· Work closely with the consumable engineering group and make recommendations for molding improvements such as use of alternate materials, parts consolidation, setup /process optimization etc. without compromising the design intent
· Conduct design concept reviews and present fresh ideas, new technologies and creative ways to take the current molding process to the next level
· Show proof of concept through rapid prototyping and supporting test data
· Take full ownership of all injection molding initiatives, coordinate with appropriate stakeholders from initial concepts through FAI, optimization, successful verification /validation, launch and documentation
· Work closely with Process Engineering through the creation of verification /validation protocols (IQ,OQ,PQ) as well as successful execution, data generation, report and documentation
· Develop /optimize molding parameters and establish best practices in molding methodologies
· Work with external companies as needed to outsource injection molding activities and manage the vendors through all phases of the projects including user requirements, RFQ, vendor selection, concept & design followed by verification /validation
· Create comprehensive work instructions and manufacturing SOP’s
· Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Qualifications
· Bachelor’s Degree in Mechanical, Manufacturing, Plastics or related engineering fields
· 7-10 years of extensive, hands-on experience with plastic injection molding including but not limited to mold design, capability studies and process characterization /optimization
· Experience with rapid prototyping and multi-cavity plastic injection molding
· In-depth knowledge of material science /plastics properties and metrology techniques
· Experience with creating engineering drawings, BOMs and product specifications
· Good understanding of DFM and lean manufacturing
· Excellent verbal, written, presentation and interpersonal skills
· Strong analytical and problem-solving skills
· Prior experience with FDA regulations and ISO, cGMP, QMS standards
· Knowledge and/or hands-on experience with machine shop tools
· Deep knowledge of GD&T as well as proficiency with SolidWorks
· Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks

Preferred Qualifications
· Knowledge /experience with micro molding
· Knowledge /experience with DOE, SPC, FMEA
· Experience with metal stamping, laser cutting and chemical etching
· Familiarity with cleaning and sterilization processes

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JOBS: May, 2019


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

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

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

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

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

Director of Manufacturing Automation – San Jose, CA

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

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

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

Director of Pilot Manufacturing – San Jose, CA

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

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

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

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WSGR 2017 Medical Device Conference


With shrinking pool of serious early stage life science investors and stringent capital requirements, the path for medtech companies has become greatly challenging.  As is the case every year, Wilson Sonsini Goodrich & Rosati 2017 Medical Device Conference provided a forum for addressing challenges faced by new medtech companies as well as opportunities presented by current trends.


Various speakers and panels addressed these issues from diverse angles and perspectives.  Following a welcome address by
Casey McGlynn, an early morning panel moderated by Donna Petkanics addressed new models for medtech investing.  Panelists Andrew ElBardissi (Deerfield Capital), Eric Milledge (Endeavor Vision SA), Leighton Read (Brandon Capital Partners), and Valeska Schroeder (KCK Group)  discussed how the investors are adapting their financing strategies and business models in response to the newer challenges that medical device companies face.  Milledge opined that it is now crucial for medtech companies to get some regulatory approval before seeking to raise money. Even CE mark could help, said Milledge. ElBardissi offered that if the company is US based and focused on US commercialization strategy then EU approval does not help. He advised that medtech companies “keep the head down and focus on US approval UNLESS there is capital efficient advantage of focusing on EU”. Schroeder said their fund was “geographically agnostic” but they believed that for an early stage medtech company it is important that they not “simply throw capital without a plan”.  but there are values you can get out which may not be revenue based but you can get close to your customer base etc… not go in every country but choosing a small no. of country to go through. Read observed that a company seeking to create larger returns must go after larger markets.

Image result for wilson sonsini medical device conference 2017With the current challenges medtech world has become more global as companies and investors are finding win-win solutions through newer models of partnering by going across continents and countries. Geographically, Pacific Rim has emerged as hot collaboration frontier. A panel moderated by Elton Satusky with CEOs Yue-Teh Jang (Medeon Biodesign), Kewen Jin (Serica Partners, Trevor Moody (M. H. Carnegie & Company), and Norman Weldon (Partisan Management Group), who completed such collaborations, financings and mergers with companies and investors in Asia discussed how these transactions may be structured.  Another panel moderated by Jack Moorman (US-Japan MedTech Frontiers – USJMF), with panelists Kenichi Hata (Terumo Corporation), Masazumi Ishii (AZCA Inc.), Yuichiro Morimoto (Enplas Corporation), and Richard Packer (Asahi Kasei Corporation) discussed collaborations between Japan and Silicon Valley.  Japan has emerged as a major partner in medtech OUS financing and growth strategy.  

Image result for medtech investmentIncreasingly there is a pressure on medtech industry that is unlike most other industries, to show value. Many organizations have now come up with ways to define and measure value creation. Among them, AdvaMed has developed a new framework to assess the value of medical technologies and diagnostics in a broad, patient-centric approach. A panel moderated by Donald May (AdvaMed) with panelists Maneesh Arora (Exact Sciences Corp), Jeff Farkas (Medtronic), and Jo Carol Hiatt (Kaiser Permanente) addressed how companies may leverage value creation to make internal business decisions to allow for more efficient use of capital and to drive discussions with potential investors as well as to keep track of milestones during the commercialization process.

AdvaMed model focuses on following drivers of value creation, 1) clinical outcomes, effectiveness and utility measures 2) non clinical patient impact including impact on caregivers, families, ease of product use, ease of care, financial impact etc. 3) new drivers around value based purchasing, care delivery costs, reduction in readmissions etc. from provider perspectives, and 4) broader public impact on population and communities in terms of whether or not the technology reduces overall cost to the system, helps identify diseases, helps employers reduce absenteeism and so on. May said the model begins with the patient and goes on to incorporate multiple stakeholders and values for all may not always be aligned or the time frames may differ. As an industry, “we need to think of appropriate levels and types of evidence as we think of new value based models of integrated care”, said May. Speakers discussed the need to move away from one number and focus on broad picture with many factors that include clinical as well as economic value, in order to get better outcomes while reducing costs.

Image result for wilson sonsini medical device conference 2017As is the case, WSGR medtech conference provides an excellent forum for investors, startups, and professionals in the industry to come together in a spirit of learning and collaboration. And compared to previous years, it seemed to be even more well attended with hallways abuzz with discussions on partnering. As always, the conference ended with short presentations from select few startups and the announcement of the $25,000 grand prize and Medtech Innovator Award.  But the best was reserved for the last. More networking happened and deals were done as attendees mingled with good food at the reception and as the best wines were uncorked and venture capitalists served as sommeliers and poured wine for the attendees.

 

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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 – April, 2012


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

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.

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.

Manufacturing/ R&D Engineer – San Jose, CA

There is immediate opening for R&D Engineer with 10+ years of deep experience in injection molding. 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.

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.

Sales Opportunity – Palo Alto, CA

There is an immediate opening for a business development/ 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. Compensation will be 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.

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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