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 under that specific opportunity). 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.
Senior Embedded Development Programmer – Mountain View, CA — Hot
A top notch product development company with a reputation for completing difficult projects on time and on budget, has an immediate opening for a programmer. The company consults for companies making wearable devices, home health, products for the aging, medical devices etc & is known for work with sensors, wireless, and motion control.
Requirements: 10+ years experience in engineering design; Embedded programming skills on Windows and/or Linux; Experience with wide range of processors; Familiarity with digital circuits; Ability to design digital circuits. Ability to design analog circuits & supervisory experience would be a plus. The person needs to enjoy working with customers and have good communication skills. The person needs to work well on a team of high performing engineers. The person needs to be organized. The person needs to work well with others and be flexible as schedules and priorities change.
QA Manager – Mount Laurel, NJ
An innovative medical device company working on treatment of chronic heart failure (“CHF”), has an immediate opening for a QA Manager. Salary commensurate with experience and will be in the range of $125-145K.
Responsibilities: Management of Quality Systems department; Direct supervision of Shipping Coordinator and Documents control; Day to day operation of all quality functions; Assure compliance with domestic and international quality requirements; Ensure comprehensive Quality Systems programs to support multiple product manufacture; Prepare and execute all external & internal audits; Work with contract manufacturer to ensure that devices are manufactured in compliance with US and international quality system requirements; Review all product complaints & ensure timely reporting of those events to domestic and international regulatory agencies as necessary; Participate in product development teams on behalf of Quality Systems. Identify and resolve quality issues throughout product development process to assure successful audits and regulatory filings; Manage, supervise and train staff, oversee projects ongoing within departments, carry out departmental administrative duties; Review and revise quality system documentation to ensure compliance with domestic and international quality and regulatory requirements; Schedule and complete timely management review presentations; Manage the document services function to ensure that quality systems documents, records and regulatory submissions are controlled; Schedule, conduct and assist in responding to internal audits; Schedule and conduct supplier audits; Maintain program to ensure adequate training of personnel on quality system documentation; Ensure that company employees are trained on the Quality Systems Regulation and key international regulations and standards; Manage the program for handling product returns, returned product evaluations (and repair/rework, where applicable), complaints and customer feedback in accordance with internal policies and procedures; Maintain a functional CAPA system in compliance with applicable regulations; Maintain ISO 13485:2003 facility registration in accordance with applicable standards; Provide guidance and supervision for Shipping/Receiving Clerk as it relates to completion of receiving inspections and other quality related functions; Ensure that the Quality Systems function is carried out in accordance with GMP and ISO directives.
Requirements: Minimum Bachelors level degree with 8-10 years’ experience in Quality area or related experience in medical device arena; Good working knowledge of domestic and international requirement and regulations; Excellent organizational skills and analytical and problem solving abilities; Strong verbal and writing skills and good interpersonal and leadership skills; Strong PC skills include Windows environment, Excel and internet. Spanish language skills desirable.
LMS eLearning Specialist – Mountain View, CA — Hot
There is an immediate opening for LMS, eLearning specialist with a medical device startup located near Mountain View, CA. Requires LMS, eLearning experience. Experience with cardiac devices and training sales team and doctors, highly desirable. Please explain specific experience in the email and send resume as an attachment.
Post Doc Opportunity – TX & CA — Lukewarm – some candidates are in pipeline
There are immediate exciting opportunities that can lead you a fantastic career path in medical device engineering. A medical device company, found by a veteran leader of several successful companies, has several post-doc openings in Biomedical with Electronics/ Electrical Engineering – with experience in heart/ brain related implantable devices in Texas and couple of opportunities with broad Biomedical/ Mechanical and/or Chemical Engineering background. Hands-on experience is essential. For Electronics Engineering, experience with hands-on circuit design, embedded systems design, prototype building or experience with battery-powered, low powered systems, etc. may be desirable. The company is working on exciting cutting edge technology to deliver large drug molecules orally. That and other research products pertain to solutions that are a unique blend of traditional device technologies such as electronics, software, mechanical engineering, and material science, as well as pharmaceuticals, protein chemistry and cell biology. Focusing on a broad range of technology and scientific disciplines, the company is seeking to address most complex unsolved or poorly treated clinical needs with highly innovative novel solutions.
Director Quality Engineering – San Jose, CA — Lukewarm – hiring was delayed & now some candidates in pipeline
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.
Manager of Data Analytics – Bay Area, CA — uncertain
This position is responsible for helping design study proposals, protocols, reports & publications & utilize knowledge of clinical epidemiology & outcomes; Design & implement health outcomes and/or economic studies from study concept stage to final report, including management of contributing personnel; Work in conjunction with a cross-functional team to develop HEOR plans & strategies; Ensure timely & quality HEOR deliverables (studies, publications, dossiers, government responses) that support development of strong value propositions for company products; assume responsibility for compliance with applicable corporate policies.
Requirements: A minimum of a Masters degree in outcomes research, the behavioral sciences, medicine, pharmacy, epidemiology, public health & health services research, & health economics or related discipline is required. Also required, 5-7 years consulting, pharmaceutical or device industry experience. Management experience preferred. Also required, Broad technical knowledge of health economics and outcomes research; Proficiency in design & executive of economic modeling studies used in dossiers supporting formulary inclusion, & pricing of pharmaceuticals/medical devices; Knowledge of clinical epidemiology & outcomes to help design study proposals, protocols, reports and publications; Knowledge of clinical services rendered in major therapeutic areas; Retrospective & prospective research experience; Large claims database management & analysis experience; SAS, SPSS and/or STATA experience; Descriptive & influential statistical techniques & analytical skills; Familiarity with the U.S medical device or pharmaceutical industry product development & commercialization process; comparable global knowledge; Excellent writing, project management, communication & presentation skills. The ideal candidate will have programming and statistical experience & experience with large databases & Experience in an HEOR environment.
Director of Public Affairs: IL — hot, but not local in Bay Area
There is an immediate opening for Director of Public Affairs at IL location for a global healthcare company focused on delivering life-improving vision technologies (including cataract, refractive & eye care products) to people of all ages. Requirements: Bachelor’s degree (Master preferred) preferably in public relations, journalism or related major; 12+ years public affairs or media experience; Experience working with senior management. Base Salary: $150 – $180K
Responsibilities: Set overall PR & communications strategy including executive, external & internal communications; determine key messages; device & execute PR programs promoting company’s market & pipeline products; engage consumers, employees & healthcare professionals, including social media channels. Lead marketing communications; develop PR programs to promote & publicize products; work with global business units & individual countries to identify opportunity for PR activities; ensure strategies/ tactics meet program goals/ deadlines & are consistent with division & corporate policies. Lead media relations; place positive stories, handle inquiries, serve as primary spokesperson with media; coordinate/supervise media visits/interviews with management; coach senior executives and third-party spokespeople on delivery of messages; oversee the PR department & PR agencies in the development of messages, press materials & other communications tools; manage approval process through business units, scientific personnel, regulatory, senior management and HQ Public Affairs & Investor Relations. Lead employee Communications; develop strategic internal communications & programs leveraging multiple media channels to inform & motivate divisional employees; research, create, edit & produce communication products, including publications & internet/intranet vehicles. Engage in crisis/Issues Management; protecting the company’s/division’s reputation & develop competitive positioning for division & its products; anticipate competitive actions, potential issues & news triggers in the macro environment (competitive actions, data publications, government actions, etc.) & develop appropriate proactive strategies & tactics; Identify & anticipate issues and counsel management on reputation/business impact in order to influence business decision making process; develop issues/crisis management plans, and oversee execution of plans; lead crisis teams on public/media issues and direct management of crisis communications, including development/maintenance of crisis tools/materials, crisis training/media spokesperson programs and development of key communications for crisis issues. Engage in executive communications; Consult with division president & senior executives to provide guidance on executive communications, including meetings and presentations to align communications with corporate and division messages. Advocacy Relations: Create, maintain and advance relationships with patient advocacy groups and professional organizations; develop and manage projects that provide mutual benefit. Site Relations: Support sites with internal/external communications strategy and materials development; issues include product line divestitures, plant expansions, manufacturing shifts, site media relations and community relations. International: Work extensively with company’s U.S. and international businesses. Develop plans and support communication needs and product promotion activities of country managers and affiliates around the world. Oversee PR agency management and conduct/oversee PR agency selection process as needed. Measurement: Set metrics to measure effectiveness of internal and external communication efforts. Division and Team Leadership: Sits on the division senior management team & regularly counsel senior management on business initiatives/programs. Fosters organizational environment that supports effective teamwork & builds collaborative alliances across the organization to resolve complex and controversial issues; set priorities for project teams and help others maintain focus in light of change; obtain & manages necessary resources to get the job done effectively; promotes a sense of urgency to achieve project goals; demonstrates an advanced understanding of the business, including financial, with ability to interpret it for various stakeholders. Department Management: Direct & manage PR department & budget; oversees contractors and PR agency resources who contribute to department and Division goals; hire and coordinate efforts of PR agencies; carry out human resource management responsibilities such as hires, job assignments, promotions, salary actions & performance reviews on time & within guidelines; responsibility for employee training and development and motivating supervised employees.
IT Project Manager, Commercial Systems – South SF, CA — Uncertain
Responsibilities: Independently and collaboratively lead a variety of projects and activities of varying size and scope, primarily in support of Commercial and Medical & Scientific Affairs (MedSA); Provide standard project management; Research and identify solutions; Define project scope and objectives; Create and maintain project schedules; Assure team’s timely completion of tasks; Estimate time requirements, establish deadlines and monitor milestone completion; Lead project teams to complete project deliverables and track progress against deadlines and budgets; Meet with appropriate personnel for periodic reviews of prototypes and final products; Assure adherence to budgets; Provide standard status reporting
Escalate key issues and awareness items as appropriate; Utilize business analysis skills to ensure a thorough understanding of user and functional requirements, dependencies and integrations; Collaborate with internal and external technical resources, as well as subject matter experts, to establish the comprehensive technical vision for a project or activity.
Requirements: 8+ years experience in a technical project management role within life sciences, preferably specializing in commercial solutions. Experience with one or more of the following technologies/solution areas strongly preferred: CRM/SFA solutions, medical information systems (e.g., IRMS), KOL/slide management systems, training and promotional content management for mobile technologies; Familiarity with Sunshine Act/aggregate spend systems a plus; Advanced MS Office skills, including Project and Visio; Familiarity with various project management methodologies (e.g., Waterfall, Agile); Reporting skills (Tableau, SQL, Crystal Reports, etc.) a plus.
Project start date is March, 24 and estimated end date is June, 24 (with possibility for extension through the end of 2014. Requires 40 hours per week. Max rate $150.00 per hour.
Director of Quality Assurance – San Ramon, CA
There is an opening for Senior Director for QA at medical technologies company that provides a broad range of mechanical circulatory support portfolio targeted towards treatment of a range of clinical needs, including chronic heart failure.
Requirements include BS in technical/ science area plus minimum of 15 years experience in the medical device industry, including medical device design, manufacturing & management experience in a complex quality assurance/ quality systems field. Knowledge & understanding of the Quality System Regulations (QSR), ISO 14385:2003 requirements & other related regulations. Extensive experience working with International regulatory bodies & with the FDA is required. Also required, competence in basic statistical methodologies & tools for analyzing data & identifying & communicating the frequency, severity & distribution of trends and a strong scientific and technical background to establish credibility with senior management as well as manufacturing & product development teams. ASQ certification (CQE/CQA/CRE/CQM) or equivalent formal training & experience and proficiency with personal computers, business software (e.g., MS Office) and technical software (e.g., Quality Management System (QMS) software), including software programs generating reports and statistics, highly preferred.
Responsibilities: Provide QA strategy & direction, with a good understanding of technical, scientific & regulatory issues. Supervise exempt department personnel at the director & managerial level & exercise general supervision over 100+ employees in the QA team. Manage the operating budget for QA. Receive inspection, supplier QA, In-Process QA, may lead FDA & other agency factory inspections and respond to nonconformities identified in internal & external audits & to CAPA actions. Provide Quality Engineering input during the Design Control, Design Review & Design Transfer processes. Participate in new product development team meetings & lead quality planning activities for new product development. Maintain oversight over sterility assurance & microbiology for new & current medical devices to assure quality compliance.
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.