Senior Product Development Engineer
Job in
Boston, Suffolk County, Massachusetts, 02298, USA
Listed on 2026-06-13
Listing for:
Shoolin Inc
Full Time
position Listed on 2026-06-13
Job specializations:
-
Engineering
Product Engineer, Biomedical Engineer, Manufacturing Engineer, Mechanical Engineer
Job Description & How to Apply Below
Employment Type:
Contract
- Design and develop medical device components, mechanical assemblies, and packaging system.
- Lead design verification and validation (V&V), feasibility studies, prototyping, and laboratory testing.
- Generate technical documentation including drawings, specifications, protocols, and reports.
- Execute risk management activities including DFMEA and UFMEA.
- Support manufacturing scale-up, technical transfers, and GMP clinical manufacturing.
- Collaborate with cross-functional teams and external partners.
- Ensure compliance with FDA, EU, and ISO standards.
- BS or MS in Mechanical Engineering, Biomedical Engineering, or related field.
- 8+ years of medical device product development experience.
- Strong knowledge of Design Controls and applicable standards (ISO 13485, ISO 14971, IEC 6236).
- Proficiency in Solid Works or similar CAD tools.
- Experience in mechanical design, GD&T, plastic part design, injection molding, and testing.
- Experience working with CMOs and suppliers.
Position Requirements
10+ Years
work experience
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