Product Development Engineering Scientist

Vertex Inc.•Boston, MA

21h•$105,600 - $158,400•Onsite

About The Position

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.

Requirements

Proven experience with Medical Device Development including ownership and/or authorship of Design and Development file records and Risk Management deliverables.
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.
B.S or M.S in engineering or another relevant discipline.
2 years of experience working within a medical device environment.

Nice To Haves

Experience with medical device packaging development and mechanical performance testing is preferred.

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.