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Staff Engineer, Systems Engineering

Company: Thermo Fisher Scientific
Location: South San Francisco
Posted on: July 14, 2021

Job Description:

Job Description

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?

Staff Engineers are key to defining and developing instrument and consumable products in the Genetic Sciences Division. This individual leads 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.

The Staff Engineer will have responsibility 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
  • 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 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.

Key experiences should include:

  • Considerable experience in developing moderate complexity integrated life sciences or clinical instrumentation, consumables, and software in an IVD environment
  • Demonstrable expertise in systems engineering processes, from requirements gathering and risk analysis to statistical power in validation
  • A solid understanding of genetic analysis tools, workflows, and chemistry in at least one of these areas: CE Sanger sequencing, qPCR, microarray, or sample preparation
  • Demonstrated experience working across multi-disciplined teams / cross - functional teams –scientists, engineers and software personnel. Demonstrated success at networking across the company.
  • Demonstratable experience in troubleshooting and root cause analysis of complex systems.
  • Excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple and changing programs/projects and priorities.
  • Experience in working with regulatory teams and knowledge of regulatory agency requirements. This includes, QSR - 21 CFR 820.30, 21CFR Part 11, ISO13485, ISO62304, and international regulatory requirements

Key people attributes:

  • Fosters collaborative relationships and builds credibility across functions/teams
  • Clear communication to product management and customer support teams

How will you get here?

Education:

  • MS/Ph.D. degree in an Engineering discipline or equivalent experience.

Experience:

  • 8+ years experience in a life science instrumentation, consumables, and assays in R&D setting, preferably in genomics
  • 4+ years experience as technical lead in new product development
  • 3+ years experience serving regulated markets in a commercial environment
  • Track record of delivering successful RUO and IVD products with a thorough understanding of quality systems
  • Demonstrated success working in a global matrixed-environment & willingness to travel up to 25%, domestic or internationally
  • Demonstrated ability to effectively build and manage internal and external relationships at senior levels
  • Critical thinking mindset mixed with creativity.
  • Demonstrated ability to map workflows to identify critical areas and/or optimize processes
EVRD2020 *GTSDouble

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

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