Product Development Engineering Senior Scientist - Medical Device & Combination Products

Vertex Inc.•Boston, MA

1d•Onsite

About The Position

The Product Development Engineering Senior Scientist focuses on combination product development, with a particular focus on drug delivery systems. The Product Development Engineering Senior 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 and Combination Product Development including ownership and authorship of Design and Development file records and leading Risk Management initiatives.
Working knowledge of development and characterization 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.
Experience with medical device and drug delivery packaging development, container closure integrity testing and mechanical performance testing.
A thorough 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.
Must be able to work independently with adequate supervision, multi-task and support several projects simultaneously.
Must demonstrate strong interpersonal and teamwork skills.

Nice To Haves

Degree in Engineering preferred but will consider other related disciplines.
Experience developing drug delivery systems is strongly 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.
Leads Design Reviews to completion, ensuring compliance with internal procedures and external standards.
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.
Must be familiar and adhere to C.T.Q. flow down.