JOBS – November, 2015

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

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

CLS Lab Manager – Santa Clara, CA

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

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

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

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

Director of Quality Engineering – Milpitas, CA

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

Director of Manufacturing Engineering – Milpitas, CA

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

Post-doc opportunity – San Jose, CA

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

Senior Biochem Scientist- San Jose, CA

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

Senior Quality Engineer – San Antonio, TX

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

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

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

Senior Clinical Data Manager – Dublin, CA

Clinical Supplies Contractor – Dublin, CA

Jobs – September, 2015

Please see below some of my immediate opportunities.  Post doc and contract opportunities are for candidates located in the United States.  But there are some new opportunities below that are located in India, for anyone wishing to do a stint in India, in very exciting, cutting edge multinational.  When sending your resume, please include details on your current compensation and compensation expectations.  Also, include in the email a short summary of your background and your key strengths. Please send resumes to wd_darshana at hot mail dot com.

VP of Engineering – Santa Clara, CA

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

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

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

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

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

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

Immediate contract Engineering Opportunities – San Jose, CA

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

Opportunities in India are posted in August JOBS posting.

JOBS – November, 2013

For the opportunities below, please send resume at wd_darshana at hotmail dot com.  Please indicate in the email how closely the job description matches your background and identify gaps, if any.  Also, indicate your current compensation and compensation expectations.  Please note: All below opportunities (except one for post doc) require several years of industry experience and are only for local candidates, with valid US work visa (except the first one which is located in Taiwan).  Also note, opportunities at the top are hot and the ones lower down may be at various stages of being filled.  I am awaiting more job descriptions and will keep adding.   Leads appreciated.

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

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

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

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

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

QA Testing Manager – Mountain View, CA

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

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

Director Quality Engineering – San Jose, CA

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

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

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

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

Head of Molecular Analysis – Mountain View, CA

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

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

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

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

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

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

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

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

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

Research Engineer – San Francisco, CA

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

General Manager – Software Engineering, Life Sciences – CA

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

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

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

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

Post-Doc ———- San Jose, CA

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

Patent Attorney – Sunnyvale, CA

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

Manufacturing Manager – Santa Cruz, CA

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

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

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

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

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

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

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

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

JOB Toulouse (Photo credit: JiPs☆STiCk)

 

JOBS – August, 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.  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 job descriptions for following positions & will be posting the details soon – Quality Assurance Engineer, Mechanical Engineer, Senior ME Technician and Software QA Tester.  Immediate need in many of the opportunities below, is experience in the area of medical injection molding.  Leads appreciated. (BTW – I love live entertainment  and if your lead results in a hire, if reminded, I will love to invite you and cover for your ticket, to accompany me to the theater for one of the upcoming plays of your choice at one of South Bay area theaters).

R&D Technician – San Jose, CA

There is an immediate opening for a Medical Device Senior Technician in an early stage company, located in San Jose, CA,  developing a novel approach for the oral delivery of large molecules.

Responsibilities: Perform experimental device component fabrication, device assembly; device testing and analysis, maintenance and troubleshooting on manufacturing equipment and process, Develop fixtures for testing or manufacturing, and Compile data on device testing.

Requirements: 5+ years work experience in an industrial or laboratory environment; experience in medical device or pharmaceutical operation, with test equipment including instron, burst, weight, pressure, and force test equipment and with basic chemistry laboratory processes including measuring, mixing solutions, chemical storage, and laboratory safety.

Also required: Demonstrated mechanical skills, Ability to read and follow written instructions, Ability to interpret engineering drawings, Familiarity with plastic manufacturing processes including molding, forming, and bonding, Familiarity with principles of machine operation, machine control systems, pneumatics, and motors, Computer skills including Word, Excel, Outlook, Ability to operate independently and function as a team member, Good written and verbal communications skills., Familiarity with principles of GMP and/or GLP operations.

Territory Account Manager for Medical Injection Molding Operations – Santa Cruz, CA

Responsibilities: Initiate and evolve customer relationships for the purpose of securing production business for company’s medical injection molding and assembly operations, located in Minnesota and California.  Activities include researching and calling potential identified customer opportunities and promoting capabilities and technology through presentations and meetings.  Interaction with internal engineering group to facilitate completion of quoting opportunities on a timely basis.  Presentation of quotes and ultimately the closing of new business.

Job Functions: Work to exceed individual/company annual sales goals; Participate in weekly sales meetings; Provide weekly sales activity reports; Sales pipeline reporting is required for the sales director, for review and discussion at the monthly managers’ financial review meeting; Work industry trade shows and follow up on leads, as required.

Major areas of accountability: Initiate and Evolve Customer Relationships to Meet Annual Sales Objectives – 75%; Account Maintenance – 20%; Monthly Reporting – 5%.

Financial Responsibility: Expense management.

Requirements: Bachelor’s Degree; Basic knowledge of molding and assembly for medical device manufacturing; Ability to understand technical drawings and related requirement information; Minimum of 2 years previous technical selling experience required.

IP Legal Secretary/ Paralegal – San Rafael, CA

Requirements : Strong docket filing experience; Thorough knowledge of patent & trademark prosecution process; Experience with Electronic Filing with USPTO and Pair; Ability to type at least 60 words per minute; Knowledge of time slips program to facilitate accounting & billing functions; Experience preparing time reports, expense reports, client bills & conflict checking forms; & Familiarity with legal terminology.  Absolutely required, 5+ years experience with patents and dockets; 5+ years experience working as legal secretary.

Responsibilities: Provide secretarial & administrative support; Assist with preparation & filing with USPTO and of foreign patent & trademark applications; Generate transmittals & formal USPTO documents;  Handle foreign patent & trademark prosecution matters including PCT & foreign prosecution forms; Monitor patent prosecution docket; Prepare & file maintenance fees, assignments, missing parts & IDSs; Proofread & redline work for accuracy of copy, format, grammar, punctuation, and syntax; Type & edit computer system legal & other documents (including memoranda, bills, timesheets & project work) from handwritten or typed materials; Copy, distribute, send by courier or express service, File & otherwise handle completed work; Receive, screen & transmit telephone calls, conference calls & messages; Handle incoming & outgoing mail; Set up & maintain files. Should work independently, take initiative, set priorities & see projects through completion; Work in a team setting.

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.

Injection Molding Tooling Engineer – Santa Cruz, CA

A contract manufacturing company has an immediate need for Injection Molding Tooling Engineer.  This position will lead and own the design, development, and procurement of all new injection mold tooling, insert mold tooling and fixtures and oversees all design changes, modifications and repairs to new and existing tooling. They will be part of the Operations team on all new product launches.

Responsibilities include, Develop primary design concepts for tooling working in conjunction with our Customers Engineering Staff and the Director of Engineering; Establishes and maintains relationships with outside tooling sources; Directly manage the construction of all new tooling with domestic and off shore tooling suppliers; Directly manage the construction of all new gauges and fixtures needed with new tools; and Communicate with supplier and customer on a technical level. Responsibilities include the establishment of technical and quality requirements for programs; Design modifications to tools and fixtures using Solidworks, or Pro E; Responsible for tracking tooling budget to quote; Work directly with the Program Managers to ensure customer and supplier terms are followed; Review of piece part prints, tolerances and GD&T and communicate requirements to Quality; Attend APQP meetings and take part in PFMEA, Control Plan and Line Documentation meetings; Direct efforts of outside tool and die shops this include selecting suppliers and reviewing and approving designs while working in conjunction with the Program Manager; Insures deliveries by outside vendors that meet the program requirements and meet established budgets for tooling procurement; Maintain CAD files associated with tooling in compliance with associated internal document control procedures; Takes part in mold start up trials at the tool maker, internally and at offsite locations; Tracks timing of tools using MS Project; Ability to tear down and maintain molds when needed.

Requirements include, Ability to manage multiple tooling sources simultaneously; An understanding of injection molding processing; Is knowledgeable in automation equipment for labor reduction efforts; Creates validation protocols; Understands and knowledge of IQ,OQ,PQ validation processes; Must be able to travel to suppliers and customers domestically, travel to tooling sources in Asia may be required.  Minimum of 10 years experience managing injection mold construction and 5 years Solid Works/ ProE Experience is required.  Also must have direct experience with managing tool construction.  Medical thermoplastic injection molding experience is a huge plus.

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.

Program Manager – Santa Cruz, CA

A contract manufacturing company, near South San Jose, has an immediate opening for Program Manager.

Responsibilities: Managing the processes by which the company designs, develops, tests and releases for production the tooling, assemblies, equipment, and facilities required to meet customer needs; Act as primary focus for NPI for customer products, directing development and transfer to manufacturing; Supporting the Sales Department in the technical aspects of new business development and customer relations; Supporting the Manufacturing Department to resolve design issues impacting the manufacturing process; Supporting the Quality Department to diagnose and document the root cause of unacceptable product and process variation; Participating in the management of the company as a member of the Management Team.

Responsibilities also include: Take charge of projects assigned and charts status; Drive customer project requirements, reporting the customer needs to management; Lead cross-functional resources, organizing a productive, capable, and skillful project team with Manufacturing, Quality and Sales; Lead vendor qualification of machine parts with purchasing; Drive customer expectations.

JOB DESCRIPTION Program Manager; Develop trusting relationship with customer; Balance company goals with customer expectations, knowing when to push back; Support operational excellence (OE) and 5S programs; Recognize problems and eliminate them before they become crises; Track costs in labor, materials and resources with precision and accuracy; Preparing and submitting billing data to the Accounting Department; Report project problems to management; Collaborating with the Sales Department to develop new equipment and facilities that will meet customer objectives; Collaborating with the Quality Assurance Manager to develop process definition, measurement and improvement for newly developed tooling; Supporting the Manufacturing Manager in the selection of manufacturing materials, manufacturing equipment and control.

Requirements: Undergraduate degree in an engineering or technical discipline; Relevant experience may be substituted for the educational requirements; Five to ten years substantiated experience in the engineering function with companies that provide highly sophisticated manufactured products; Experience in the medical, bio-technology and other high technology industries strongly preferred; Experience in dealing with customers is strongly preferred; Must demonstrate expertise in a variety of concepts, practices and procedures common to the manufacturing industry; Project a neatly groomed, confident appearance and be effective with public speaking and direct client interface.

The environmental conditions in which the Program Manager will perform his/her duties are an open office. This position will require visits to client sites in all types of weather. The normal travel hazards will apply including driving and flying in a variety of traffic and weather conditions.

Other Requirements: The physical demands of the position are listed in accordance with the requirements of the American with Disabilities Act. They are outlined on the attached Checklist: Good reading, writing and verbal skills to communicate clearly and effectively in the English language to customers and company personnel; Intermediate capability in engineering and project management software; Computer literate in Word, Excel and Power Point with full competency in sourcing Internet material; Ability to maintain a flexible work schedule to meet the demands of the job. Some evening and weekend work may be required; High tolerance for stress and deadlines

Performance Criteria: The Program Manager’s performance is satisfactory when the following have occurred: New programs have been completed to the satisfaction of management and the customer; Responses to Requests for Quotes are submitted to the Sales Department when committed; The management team is always informed of the status of new programs; Billing information is submitted to the Accounting Department in time to support the billing process; Required reports are accurate and submitted on time.

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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.