Product Development Engineering Scientist

Role: Product Development Engineering Scientist specializing in combination drug-device and biologic device products, focusing on drug delivery systems. Responsibilities: author design history documentation, conduct risk analyses (DFMEA, UFMEA, PFMEA, biocompatibility), translate user requirements into design inputs, manage change controls and deviations, and maintain Design History Files; ensure documentation completeness and alignment with development and manufacturing needs. Requirements: degree in Engineering (PhD with up to 3 years, MS with 3+ years, BS with 6+ years); proven experience in medical device development, risk management, and design file ownership; knowledge of Test Methods, cGxP, ISO 13485, ISO 14971, and 21CFR 820; strong technical writing and presentation skills; experience working in highly matrixed environments. Preferred: experience with device packaging development and mechanical performance testing. HighValue: combination product development, drug delivery systems, medical device risk management, design history documentation, regulatory compliance (cGxP/ISO 13485/21CFR). WorkSetup: on-site five days/week with ad hoc flexibility.