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

HOW WILL YOU MAKE AN IMPACT?

Join the forefront of innovation in genetic analysis for research & clinical applications. As the leading provider of genetic analysis solutions, we have a great impact worldwide. Our teams develop platforms, consumables, and reagents that help fight COVID-19 pandemic, realize justice, ensure reproductive health, accelerate disease research, advance methods for syndromic testing of infectious diseases, and keep the world’s food supply safe. Come help our customers make the world healthier, cleaner, and safer!

WHAT WILL YOU DO?

You will develop instruments, consumables and reagent products in the Genetic Sciences Division by leading system definition and system integration efforts. Through collaboration with highly technical engineering professionals and scientists, the team will develop research and regulated systems for our premier platforms in qPCR, Capillary Electrophoresis, Rapid DNA, Flow Cytometry, Microarray, NGS and other life science platforms.

• Develop new instrument systems and support current Thermo Fisher products
• Partner with the Product Management and Applications teams to define systems architecture, establish feasibility, complete integration and hold other development roles
• Lead evidence-based decisions across all functions
• Understand clinical and RUO customers to effectively translate their needs into product requirements
• Work with subsystem owners to craft sophisticated systems and clinical workflows from beginning to end. This includes leading design reviews, DFMEA, and design documentation.
• Plan, develop, and analyze system integration
• Maintain requirement traceability in conjunction with subsystem requirements owners
• Work hand-in-hand with the Operations team to transfer products into manufacturing

HOW WILL YOU GET HERE?

EDUCATION

BS/MS/PhD. degree in Bioengineering, Biomedical Engineering, Chemical Engineering, Biochemistry, Molecular Biology, Applied Physics, or related technical discipline

EXPERIENCE

• 3+ years’ experience as technical lead in new product development with analytical instrumentation
• Knowledge of systems engineering processes, from requirements gathering and risk analysis to statistical power in validation. Solid understanding of Systems Engineering principles, DfX, DOE, Statistical Analysis methods, proficiency in using MATLAB/Simulink, JMP or equivalent SW platforms
• History of delivering successful RUO and IVD products with a detailed understanding of quality systems
• Demonstrated ability to effectively work across multi-disciplined teams / cross-functional teams (scientists, engineers, and software personnel) and success in networking and building relationships across the business
• Willingness to travel up to 25%, domestic or international

PREFERRED EXPERIENCE

• Experience in developing moderate complexity integrated life sciences or clinical instrumentation, consumables, and software in an IVD environment
• A solid understanding of biotechnology tools, workflows, and chemistry in 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
• Experience working with regulatory teams and knowledge of regulatory agency requirements
• Experience in usability engineering is a plus

KNOWLEDGE, SKILLS, ABILITIES

• Maintain collaborative relationships and builds credibility across functions/teams
• Inspires, influences, and empowers colleagues across a global matrix to achieve goals
• Ability to work in high performance teams to create impactful plans and carry out effective execution to assure that critical deliverables complete within project timelines
• Maintain 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

RELOCATION ASSISTANCE WILL 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

As the world’s leader in serving science, Thermo Fisher Scientific's professionals develop critical solutions—and build rewarding careers. They help customers in finding cures for cancer, protecting the environment, making sure food is safe, and so much more. When you #StartYourStory with Thermo Fisher, you are guaranteed meaningful work - both personally and professionally.