Product Development Engineering Senior Scientist - Medical Device & Combination Products

Key Duties And Responsibilities Collaborate with cross‑functional teams to author design history documentation for combination drug‑device and/or biologic device products. Author risk analyses, including DFMEA, UFMEA, PFMEA, and biocompatibility risk assessments. Translate User Requirements into Design Requirements; correlate Design Inputs with Design Outputs; support Design Verification and Validation studies (internal/external as needed). Lead Design Reviews to completion, ensuring compliance with internal procedures and external standards. Manage change control, deviations, and non‑conformances for impact assessment and investigations; ensure timely completion and updates to the Design History File. Maintain the Design History File, including review/revision of applicable Design and Quality System documentation. Ensure completeness and alignment with User Requirements, Functional Requirements, Design Inputs; adhere to C.T.Q. flow down. Knowledge And Skills (Qualifications) Proven experience in medical device and combination product development; ownership/authorship of design and development file records; leading risk management initiatives. Working knowledge of development/characterization of test methods for component/sub‑system/assembly selection, verification, and validation. Ability to present to cross‑functional teams and update design and risk files. Experience executing workstreams in highly matrixed environments. Experience with medical device/drug delivery packaging development, container closure integrity testing, and mechanical performance testing. Strong understanding of cGxP; ISO 13485, ISO 14971, and 21 CFR 820. Strong statistical principles; technical writing and presentation skills. Work independently, multi‑task, and support multiple projects; strong interpersonal/teamwork skills. Education And Experience PhD (2+ years) or MS (5+ years) or BS (8+ years). Engineering degree preferred; other related disciplines considered. Experience developing drug delivery systems strongly preferred. May require occasional travel to other locations. #J-18808-Ljbffr