Staff Engineer, Systems Engineering
Company: Thermo Fisher Scientific
Location: South San Francisco
Posted on: July 14, 2021
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
- 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
- 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
- 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
- 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
Key people attributes:
- Fosters collaborative relationships and builds credibility
- Clear communication to product management and customer support
How will you get here?
- MS/Ph.D. degree in an Engineering discipline or equivalent
- 8+ years experience in a life science instrumentation,
consumables, and assays in R&D setting, preferably in
- 4+ years experience as technical lead in new product
- 3+ years experience serving regulated markets in a commercial
- 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
Keywords: Thermo Fisher Scientific, South San Francisco , Staff Engineer, Systems Engineering, Other , South San Francisco, California
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