About the Role
We are looking for a Staff Engineer to lead the development of advanced flow cytometry and cell analysis systems from concept through verification and validation. This role combines systems engineering, product development, and technical leadership, bringing together hardware, software, firmware, optics, fluidics, electronics, and reagents to deliver innovative solutions that meet customer needs. You will work across the full product lifecycle, translating user requirements into system requirements, guiding system integration and characterization activities, and supporting the successful delivery of complex products within a regulated environment. This is a hybrid role requiring a minimum of three days per week on site and in the laboratory.
Responsibilities
- Define and manage system-level requirements for complex life science and diagnostic platforms.
- Collaborate with mechanical, electrical, software, firmware, and reagent teams to develop integrated solutions.
- Lead system characterization, performance evaluation, and root cause investigations.
- Develop, review, and execute test strategies, protocols, and performance studies.
- Support risk management activities including hazard analysis and design reviews.
- Guide system integration efforts and ensure design integrity throughout development.
- Provide technical leadership on complex projects and mentor engineers across the team.
- Contribute to verification and validation activities within a regulated product development environment.
Qualifications
- Bachelor's degree in Biomedical, Electrical, Mechanical, Chemical, Physics, or a related engineering discipline; advanced degree preferred.
- Significant experience in systems engineering, product development, or product design within life sciences, diagnostics, or medical devices.
- Knowledge of flow cytometry, cell analysis, optics, fluidics, electronics, embedded systems, software, or assay reagents preferred.
- Experience with requirements management, system architecture, verification and validation, and design control processes.
- Familiarity with regulated environments, including FDA regulations, quality systems, and compliance requirements.
- Ability to lead complex technical initiatives and influence project direction through sound engineering judgment.