Staff Systems Engineer - IVD

Company: Thermo Fisher Scientific
Location: South San Francisco
Posted on: November 20, 2020

Job Description:

Job Description:

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Location/Division Specific Information: * South San Francisco, CA * Genetic Sciences Division Join the forefront of innovation in genetic analysis for research & clinical applications. Our teams develop platforms, consumables, and reagents that help bring criminals to justice, ensure reproductive health, accelerate disease research, advance methods for syndromic testing of infectious diseases and viruses, and keep the world's food supply safe. As the leading provider of genetic analysis solutions and leveraging the resources of a $24B enterprise, our technologies have great impact worldwide. And as a member of our team, you can play a critical role in helping us fulfill our global mission of making the world healthier, cleaner, and safer. How will you make an impact? Systems Engineers are key to defining, developing, and validating instrument and consumable products in the Genetic Sciences Division, including tests for COVID-19. Working alongside a senior systems engineer, this individual will assist with system definition & system integration aspects of product development in collaboration with highly technical and specialized engineering professionals and scientists to develop instruments and applications for our world class qPCR, Capillary Electrophoresis, Rapid DNA, and Microarray platforms in both RUO and IVD markets. What will you do? The Systems Engineer will be responsible for providing direction and focus to drive Division objectives as follows: * Partner with our Product Management teams to define system architecture and integration design, development, feasibility testing. * Understand clinical customers and effectively translate their needs to product requirements, experience in usability engineering is a plus * Work with cross-functional subsystem owners to design and develop integrated systems from beginning to end of the clinical sample workflow(s) including leading stage gate design reviews, d/pFMEA processes, and design documentation. * Plan, develop, and analyze system integration in order to maintain requirement traceability through various subsystems and verification activities in collaboration with subsystem requirements owners * Contribute to the design of system verification and validation activities for regulated products * Contribute to data-driven decision making by designing experiments, analyzing, and presenting results * Work hand-in-hand with the Operations team to transfer your products into manufacturing. How will you get here? Education/Experience: * PhD in Bioengineering or related discipline AND one (1) year of relevant industry/academic wet lab experience using a variety of laboratory techniques; OR Master's degree in Bioengineering or related discipline AND three (3) years of relevant industry/academic wet lab experience OR Bachelor's degree in Bioengineering or related discipline AND seven (7) years of relevant industry/academic wet lab experience using a variety of laboratory techniques. * Experience in a life science instrumentation, consumables, and assays in R&D setting, preferably in genomics * Experience serving regulated markets in a commercial environment * Track record of delivering successful RUO and IVD or medical device products with a thorough understanding of quality systems Key experiences should include: * Experience in developing moderate complexity integrated life sciences or clinical instrumentation, consumables, and software in an IVD environment * Experience in systems engineering processes, from requirements gathering and risk analysis to statistical power in validation is a plus * An understanding of genetic analysis tools, workflows, and chemistry in at least one of these areas: CE Sanger sequencing, qPCR, microarray, or sample preparation * Excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple and changing programs/projects and priorities. Key people attributes: * Fosters collaborative relationships and builds credibility across functions/teams * Inspires, influences, and empowers employees across a global matrix to achieve goals * Able to decisively lead and empower teams to develop impactful strategies and plans * Maintains a high level of professional expertise through familiarity with current engineering/scientific literature, competing technologies, and/or products as well as attendance of seminars and meetings. Knowledge, Skills, Abilities: * Ability to think critically and desire to drive constant improvement * Highly data-driven/detail oriented and ability to under

Keywords: Thermo Fisher Scientific, South San Francisco , Staff Systems Engineer - IVD, Other , South San Francisco, California