About You
You have a strong quantitative background and like working across disciplines. You are comfortable navigating both the rigor of a structured development process and the ambiguity inherent in early-stage product development. When two teams are solving the same problem with different assumptions, you notice early and get them realigned.
Requirements- Keep one shared picture of what the system must do. Ensure that requirements are being addressed and defined in development, and track them in a requirements management tool. Translate market and user needs into clear, testable design inputs across biology, hardware, and software.
- Define and maintain the interfaces between mechanical, electrical, fluidic, software, and cell biology subsystems so teams can build in parallel without surprising each other. Maintain the interface control documents and system block diagrams that record those agreements, and raise integration risks while they are still cheap to fix.
- Support verification and validation planning at the subsystem and system level, and maintain the system risk analyses that drive it. Make sure risk mitigations land in the requirements and get verified, and work with quality and regulatory to keep DHF artifacts current as designs settle.
- Help with prototype assembly and testing. Work alongside the engineering and biology teams on builds and test runs, and feed what you learn back into the requirements and interfaces.
- Contribute to program planning and milestone tracking with the functional leads, and flag schedule and technical risks early.
Qualifications
- Bachelor's or Master's degree in an engineering or scientific discipline, or equivalent industry experience.
- Typically 5+ years at the intersection of biology, chemistry, and instrumentation.
- Systems engineering experience building and maintaining a requirements set in a requirements management tool (e.g., DOORS, Jama, Flow Engineering), ideally through the transition from research to product development.
- Experience keeping multiple engineering teams aligned: running design reviews, resolving requirement conflicts, and settling interface disagreements.
- Experience working within a QMS, including design history files and supporting design artifacts.
- Hands-on laboratory experience and comfort collaborating with bench scientists.
Preferred Qualifications
- Experience in cell therapy manufacturing or another regulated bioinstrumentation product.
- Track record working in an interdisciplinary R&D / early product development setting.
- Familiarity with model-based systems engineering (MBSE) methods and tools.
- Experience using AI tools in engineering work, such as requirements drafting, documentation, andor literature review.
BenefitsCompetitive salary and benefits package, including Medical, Dental, Vision, and 401k match.
Salary Range: $115,000 - $135,000, commensurate with experience
Benefits: We offer our employees comprehensive benefits, including medical, vision, and dental coverage, as well as retirement savings plans. Optional benefits include accident and term life offerings.
