Sr. Staff Systems Engineer, Technical Lead

Job Title: Senior Staff Systems Engineer, Technical Lead

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

Genetic Services Division. South San Francisco

How will you make an impact?

Join the forefront of innovation in genetic analysis for research & clinical applications. Our teams develop platforms, consumables, and reagents that help fight COVID-19 pandemic, 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 our resources, our technologies have great impact worldwide. 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.

What will you do?

Senior Staff Systems Engineers are key to 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.

• Act as a thought leader in developing new qPCR instrumentation and supporting current ThermoFisher instruments
• Partner with our Product Management teams to define qPCR systems architecture and integration design, development, feasibility testing.
• Understand clinical and RUO customers to effectively translate their needs into 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, dFMEA 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.

How will you get here?

MS/Ph.D. degree in an Engineering discipline or Applied Physics

• 5+ years’ experience as technical lead in new product development with analytical instrumentation, preferably qPCR
• 3+ years’ experience serving molecular diagnostics markets in a regulated 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

Preferred Experience:

• 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.
• 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

Knowledge, Skills, Abilities

• 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.

Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.