JOBS – October, 2013


There is a nice steady pickup in Life Science Job Market.

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.  Also note, opportunities at the top are hot and the ones lower down may be at various stages of being filled.  Also, I am awaiting more job descriptions and will keep adding.  Leads appreciated.

Director Quality Engineering

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.

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.

Senior Validation and Quality Engineer – San Jose, CA

There is an immediate opening for a Senior Validation and Quality Engineer in an early stage company developing a novel approach for the oral delivery of large drug molecules.
Responsibilities: Develop test strategies DOEs and test protocols to test developmental medical devices and manufacturing processes.; Analyze and report on test results ; Develop, implement, and maintain documentation system; Put together Quality manual; Develop strategy and manage and shift products to GMP/GLP operation.
Skills Required: Degree in an engineering discipline; CQE Certification; Expertise with statistical analysis using Minitab, Jump or similar; Expertise with Documentum or similar document control system; Strong ability to operate as a team member in a development environment.; Excellent written and verbal communications skills.
Experience Required: Five to ten years work experience in quality role in GMP environment; Experience either in medical device or  pharma development environment.

Software Quality Assurance (SQA) Engineer – San Francisco, CA

A software company that provides innovative, modular, scalable and world class solutions by leveraging state of the art sensor technologies, cloud computing, big data analytics, and complex event processing, is scaling, in pre-funding stage.  The company is expanding core engineering and product development team & looking for high caliber, senior, Quality Assurance Test Engineers, with interest in working with cutting edge technologies in a high energy entrepreneurial environment.

Responsibilities: Acquire in-depth understanding of the company’s products to ensure high quality of products; Support the development of workarounds, testing, necessary documentation (including investigation and resolution of issues; Assist in coordinating delivery management tasks; Track requirements and software release management for clients; Be first escalation point for supporting company’s customers.

Requirements: Must have strong client support & project management background.  Must have 4-6 years of implementation & post production support experience for enterprise applications; 3-4 years of functionality, testing, bug tracking, writing test cases experience; strong communication skills; demonstrable hands-on experience with quality management tools; technical skills in SQL, HTML based documentation.  Highly preferred: skills in developing and managing on-line help content.

Location: San FranciscoBay Area.  Telecommuting is okay but will need to attend client team meetings – so must be in driving distance.  Duration: 6-12 months, full to part-time, 1099, corp to corp, contract to hire.  No visa sponsorships.

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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Pharmacologist with Large Animal Survival Surgery Experience: San Jose, CA

A dynamic company, founded by a veteran leader, 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 candidate must have hands-on research experience including in vivo experience esp with large animal models during their doctoral and post-doctoral training period. The ideal candidate will have a Ph.D. in Physiology/Pharmacology or any other related Biology discipline or a DVM with research experience. The individual is expected to have a breadth of experience in both 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 individual 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 individual will set up and run a variety of routine in vitro research paradigms in house 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 individual will work with a multidisciplinary team of experts and provide biology support with minimal supervision on various ongoing projects.

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