Posts Tagged QA

JOBS – December, 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 require several years of industry experience and are only for local candidates, with valid US work visa (when need arises for applicants with other types of visas, I will mention that).  Also note, opportunities at the top are hot and the ones lower down may be at various stages of being filled or not burning needs.  I am awaiting more job descriptions and will keep adding.   Leads appreciated.

ios/ Android Developers – Bay Area, CA
Immediate need for health-IT company.

Senior and Junior Bioinformatics Scientists – San Ramon, CA

An organization near San Ramon, CA, dedicated to leveraging a range of transformational digital medical technologies in medical imaging and information technologies, medical diagnostics, patient monitoring, disease research, drug discovery & biopharmaceutical manufacturing technologies, has an immediate openings for Bioinformatics Scientists at Senior and Junior level.  Below description is for senior role.

Responsibilities: Bioinformatics developer will work with scientists & engineers for development of systems software within medical diagnostics. The position may also develop distributed software application for subsystems that enable the business strategic imperatives.  Essential functions: Develop robust bioinformatics software solutions to support company’s medical diagnostic activities; Work closely with systems teams in requirements gathering & software design; Interact with global teams to promote consistency & maximize synergies across common software platforms; Design & build strong testing infrastructure to minimize dependency on hardware availability; Leverage DFR for software, Agile & Lean software development methodologies to drive reliability upstream into the product development life cycle.

Requirements: MS or Ph.D. in Bioinformatics or Molecular Biology with a minor in Computer Science, Statistics or Computational Biology; 5+ years experience in combining knowledge of chemistry, physics, and/or biology with software engineering; 3+ years experience in programming using Pearl and/or Python; 2+ years experience with SQL, preferably MySQL; 2+ years experience with statistical programming (e.g. R, MATLAB).

Regulatory Affairs Director – Mount Laurel, NJ, & Orangeburg, New York (and another similar opening in Bay Area, CA)
(mention location preference when sending in the CV)

There is an immediate opening for Regulatory Affairs Director in a medical device company with innovative treatment of chronic heart failure built around CCM technology.  RA Director Will be responsible for RA and for Quality systems.

Responsibilities: Domestic & international submissions & approvals for all new & existing products; Assuring compliance with domestic & international quality and regulatory requirements; Assistance with design & implementation of clinical trials to support new & existing products; Represent company with FDA, Notified Body &  international regulatory agencies regarding company’s regulatory strategies & submissions; Determine strategy, content & structure of domestic & international regulatory filings & quality assurance strategies; Maintain quality system & current product documentation & labeling in compliance with new standards, directives & requirements; Assist in design & implementation of clinical studies in support of new & existing products.  Act as liaison with clinical function; Represent the company with all domestic & international regulatory agencies including all verbal & written communication to & from the company; make all final decisions regarding all Quality System related activities; Review all product complaints & ensure timely reporting of those events to domestic & international regulatory agencies as necessary; Review & revise quality system documentations; Schedule, ensure completion of, manage & respond to all audits; Ensure training of employees on Quality Systems Regulation & key international regulations & standards; Manage the program for handling product returns, returned product evaluations (repair/rework, where applicable), complaints & customer feedback in accordance with internal policies and procedures; Maintain ISO 13485:2012 facility registration in accordance with applicable standards; Participate in product development teams on behalf of Regulatory & Quality Systems; Ensure that the Quality Systems function is carried out in accordance with GMP & ISO directives; Prepare &  submit regulatory submissions to obtain approval to conduct domestic & international clinical investigations & to seek regulatory approval to commercialize new & existing devices & their accessories.

Requirements: Bachelor in science / engineering with at least 5 years’ experience in Regulatory/Clinical/Quality area or related experience; Regulatory/Clinical/Quality experience with Class 3 medical device; Regulatory experience in the Implantable field – highly preferable; Excellent working knowledge of domestic & international requirements, regulations & standards applicable to medical electrical devices – highly desirable; Proven experience with at least one complete medical device submission to a EU Notified body and the US FDA involving a device subject to the 60601-1 3rd edition standard; Thorough understanding of the MDD (Medical Device Directive); Previous direct interaction with the FDA & an EU Notified Body; Excellent working understanding of requirements & implementation of Quality Systems compliant with US & international requirements for medical device manufacturers; Previous experience assuring that the Quality Systems function is carried out in accordance with GMP & ISO directives; Ability to analyze & perform commercial risk management in the context of regulatory & quality requirements.

Director of Quality Assurance – Palo Alto, CA

Details to follow.

Senior Manager/ Director of Mechanical Engineering – San Jose, CA

There is an immediate opening for hands-on 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 will be responsible for building the team and effectively leading multi-project R&D efforts of the organization through technical expertise, interpersonal skills & a clear vision for execution.  Stock options and cutting edge technology makes it highly attractive opportunity for the right candidate.

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.

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 to map task interdependencies, multi-task, prioritize such tasks, meet deadlines, and develop, monitor and live within budgets as well as the demonstrated ability to forecast major milestones.  Must be skilled at delegation, follow-up, and team building.

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.

Research Engineer – San Francisco, CA

A company that has developed advanced consumer health sensing technology, has an immediate opening for research engineer.  Responsibilities include, research and implement cutting edge physiological sensors and algorithms and work closely with research and device teams to integrate research into company’s consumer product portfolio.

Requirements: MS or PhD in biomedical engineering, electrical engineering, or related discipline; Minimum of 2-4 years (or academic equivalent) experience in physiological data collection, interpretation and analysis; Proficient in common signal processing techniques including time series analysis, adaptive filters, and noise cancellation; Demonstrated ability in a scientific computing language (e.g. Python, R, Matlab).
Also preferred: Experience developing algorithms for  physiological signals such as heart rate, temperature, perspiration or body motion accelerometry; Proficiency with machine learning and statistical modeling; Experience with data handling and storage, e.g. NoSQL database systems

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 but OPT visa may be ok. Pay: rate negotiable. Open to considering excellent part-time candidates.

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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.

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Pitfalls and traps in medical documentation


Pitfalls and traps in medical device & biotech documentation

Connie Hoy, VP of RA-QA at Cutera, discussed essentials of document writing to avoid the pitfalls and traps, 483s, consent decrees, lawsuits, and litigation, at http://www.bio2devicegroup.org event. With clear and precise examples, the presentation highlighted some of the common mistakes that are made in generating documentation that can lead to non-conformities during inspections and costly payments during litigation.

Any kind of vague and ambiguous language should be avoided in the documents. The traps described below, may seem easy to avoid but in reality, it is easy to fall into those traps.
1) Writing in a passive voice: This is a trap where the subject of the sentence denotes the recipient of the action, rather than the performer. For instance, “injury occurred to patient” instead of “the patient was injured”. Writing in a passive voice will make it more challenging to get past the FDA and it should be avoided in complaints, non conforming investigation, CAPA etc.
2) Not presenting the facts: Documents should contain facts. What would constitute facts? A fact is what can be checked and verified by the observer. For instance, “the drug was used in animal study comprising of 8 dogs and no side effects were observed”, as opposed to “the drug is safe” or “cause of the problem is due to user error”. A substantiated statement, consisting of a fact, provides justification for the reader to believe that what is written is, in fact true.
3) Incomplete or ambiguous documentation: Documents should not be incomplete, unfinished, imperfect, or left uncertain.
4) Too much information: Documents should be concise, complete, self-contained, an auditable. Too much information lends itself to the possibility of vagueness and ambiguity. If needed, additional information (e.g. back and forth email exchange) should be included in the addendum. Concise documentation should be appropriately filed so it is easy to retrieve, when needed. During an audit, how quickly documents are retrieved can often give an indication of their brevity and completeness.
5) Email sandwich: Avoid email sandwich where a document is followed by emails and that is followed by a document. When necessary, the emails should be referred to in the document and filed separately in the appendix.
6) Not distinguishing between correctness and corrective action: A correction is an action to eliminate a detected non conformity and may include, rework, upgrade, recall etc. A corrective action is an action to eliminate the cause of a detected non-conformity, and may involve design change to prevent recurrence of the issue. And a preventive action is an action to eliminate the cause of the potential non-conformity or other undesirable situation and it may include for instance, a design change to prevent occurrence of the issue.

The interactive presentation included many with real life examples and brainstorming with the group. In conclusion, Hoy shared real-life example where in 2010, Cutera had earned several adverse reports that were MDRs on its Titan Handpiece. She discussed the steps that were taken and included opening a CAPA, doing an investigation using returned handpieces and new handpieces, determining that the root cause was parts failure due to material used in the part, taking corrective action of redesigning the part, performing a health hazard evaluation that determined that the company needed to conduct a recall, recalling 100% of the handpieces and replacing defective parts i.e. doing correction, updating risk management file, and finally taking preventive action with new material to be used in all new designs.

The presentation was followed by Q&A. Connie Hoy can be reached at choy@cutera.com .

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