Sr. Staff Development Scientist

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At Beckman Coulter Diagnostics, one of Danaher’s () 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

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As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year.

From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence.

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The Sr. Staff Development Scientist is responsible for leading complex antimicrobial susceptibility testing (AST) development programs, driving DOE-based experimental strategy and technical decision-making across multiple development projects, and partnering cross-functionally to advance products from feasibility through regulatory clearance.

This position reports to the Director, R&D Assay Development, Microbiology and is part of the Development Science team located in West Sacramento, California and will be an on-site role.

• Lead 2-3 concurrent development projects or one multi-project program, establishing technical strategy, aligning major work streams, and driving execution across Development Science.
• Lead development and optimization of antimicrobial susceptibility testing (AST) assays, creating complex, statistically sound experimental designs using Design of Experiments (DOE) methodologies.
• Serve as the Development Science subject matter expert, guiding programs from feasibility through regulatory clearance, including authoring and approving design control documentation.
• Partner with Regulatory Affairs, Manufacturing, Clinical Affairs, Systems Engineering, Software, and Program Management to resolve complex technical issues and support audits, risk management, and CAPA investigations.
• Mentor and develop scientific staff, leading technical reviews, and building training programs and knowledge-sharing tools that strengthen organizational capability.

• Demonstrated experience leading complex AST (antimicrobial susceptibility testing) assay-development programs or comparable regulated diagnostic product-development programs.
• Demonstrated expertise in Design of Experiments (DOE) creation, advanced data analysis, and evidence-based technical decision-making.
• Experience supporting the full development lifecycle from feasibility through regulatory clearance, including demonstrated 510(k) submission experience.
• Experience authoring design control documentation and supporting audits, risk management, CAPA investigations, verification, and design transfer.
• PhD in Microbiology, Molecular Biology, Biochemistry, or a related discipline with 9+ years of experience; OR Master’s degree with 12+ years of experience; OR Bachelor’s degree with 14+ years of experience.

• Ability to travel occasionally (estimated less than 10%) to support in-person collaboration with CROs, vendors, universities, or other external development partners, as needed.

• Experience providing…