Product Development Engineering Scientist

General

Summary:

The Product Development Engineering Scientist focuses on combination product development, with a particular focus on drug delivery systems.

• 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.

• 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 work streams 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.

• Degree in Engineering preferred (other related disciplines considered).
• PhD (0–3 years), M.S. (3+ years), or B.S. (6+ years).

$105,600 - $158,400