Thermo Fisher Scientific
180 Oyster Point Blvd
South San Francisco, CA 94080
Comprehensive benefits & bonus package
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 $25B 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.
Location/Division Specific Information
South San Francisco, CA / Genetic Testing Solutions
How will you make an impact?
As a Senior Manager, you are key to providing direction and focus to drive division objectives. You will lead and manage a team that defines system aspects of product development in collaboration with highly technical and specialized engineering professionals and scientists to develop instruments and applications for our world class platforms in both RUO and IVD markets.
What will you do?
• Partner with 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
• Capture, prioritize, track and drive closure on issues including risks and mitigation plans
• 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 a technical Engineering discipline or Applied Physics
• 10+ years experience in developing life science or clinical instrumentation, consumables, and assays in R&D setting, preferably in genomics
• 5+ years experience as technical lead in new product development
• 3+ years experience serving regulated markets in a commercial environment
• Track record of delivering successful IVD products with a thorough understanding of quality systems
• Previous experience working with regulatory teams and knowledge of regulatory agency requirements including QSR - 21 CFR 820.30, 21CFR Part 11, ISO13485, ISO62304, and international regulatory requirements
• Demonstrated success working across multi-disciplined teams / cross-functional teams –scientists, engineers, and software personnel in a global matrixed environment and fostering collaborative relationships and builds credibility across functions/teams
• Mentored and developed junior staff and empowered teams to develop impactful strategies and plans
Knowledge, Skills, Abilities
• Expertise in systems engineering processes, from requirements gathering and risk analysis to statistical power in validation
• 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
• Excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple and changing programs/projects and priorities
• Ability travel up to 25%, domestic or internationally
Relocation assistance may be provided to those that qualify.
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.
Apply today! http://jobs.thermofisher.com
How to Apply
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About Our Organization
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue exceeding $30 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. Our global team of more than 80,000 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