Product Development Engineering Scientist

General Summary: The Product Development Engineering Scientist focuses on combination product development, with a particular focus on drug delivery systems. Key Duties And Responsibilities: Collaborate with cross-functional teams to author design history documentation of 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 (internally and externally). Manage Change Control, Deviations and Non-conformances with cross-functional teams for impact assessment and investigations; ensure timely completion and updates to the Design History File. Perform Design History File maintenance, including review/revision of Design and Quality System Documentation. Ensure completeness and alignment with User Requirements, Functional Requirements, and Design Inputs. Knowledge And Skills: Proven experience with Medical Device Development, including ownership/authorship of design and development file records and risk management deliverables. Experience with medical device packaging development and mechanical performance testing (preferred). Working knowledge of test methods for selecting, verifying, and validating components/sub-systems/assemblies. Ability to present to cross-functional teams for input and design/risk file updates. Experience executing workstreams in highly matrixed environments. Strong understanding of cGxP principles and practices; ISO 13485, ISO 14971, and 21C.F.R.820. Strong statistical principles; strong technical writing and presentation skills. Education And Experience: Degree in Engineering preferred (other related disciplines considered). PhD (0–3 years), M.S. (3+ years), or B.S. (6+ years). Pay Range: $105,600 - $158,400 #J-18808-Ljbffr Scorpion Therapeutics