Product Development Engineering Scientist

General Summary:

The Product Development Engineering Scientist focuses on combination product development, with a particular focus on drug delivery systems. The Product Development Engineering Scientist will work closely with Research and Development, Device Quality Control, Device Quality Assurance, Process Development, Clinical/Commercial Packaging & Labeling Functions, Regulatory Affairs, and Manufacturing Functions, as required.

Key Duties and Responsibilities:

• Collaborate with highly cross-functional teams to author the design history documentation of combination drug-device and/or biologic device products.
• Author Risk Analyses, including DFMEA, UFMEA, PFMEA, and biocompatibility risk assessments.
• Translates User Requirements into Design Requirements as appropriate. Correlates Design Inputs with Design Outputs and supports Design Verification and Validation Studies (as needed) to be executed both internally and externally.
• Manage Change Control, Deviations and Non-conformances with Cross-Functional Team for Impact Assessment and Investigations, and manage timely completion of activities while ensuring updates are made to relevant documents in Design History File.
• Perform Design History File maintenance as required, including – as applicable – review and revision of all Design and Quality System Documentation.
• Display an eye for completeness, ensuring enough detail is captured for Process Development and Manufacturing purposes. Aligns with User Requirements, Functional Requirements, and Design Inputs as appropriate.

Knowledge and Skills:

• Proven experience with Medical Device Development including ownership and/or authorship of Design and Development file records and Risk Management deliverables.
• Experience with medical device packaging development and mechanical performance testing is preferred.
• Working knowledge of Test Methods for selection, verification and validation of components, sub-systems and assemblies.
• Able to present to cross-functional team for input, alignment, and design and risk file updates.
• Must have experience executing workstreams in highly matrixed environments.
• A strong understanding of cGxP principles and practices, ISO 13485, ISO 14971, and 21C.F.R.820.
• A strong understanding of statistical principles is required, as are strong technical writing and presentation skills.

Education and Experience:

• B.S or M.S in engineering or another relevant discipline.
• 2 years of experience working within a medical device environment.