Title: Sr Combination Product Development Engineer (Drug–Device Systems)
Location: Providence, RI
Employment Type: 6+ months Contract
Status: Accepting Candidates
About the role
This role supports the development of complex combination drug-device and biologic products within a highly regulated environment. You will collaborate with cross-functional teams to drive design, risk management, and lifecycle development from concept through commercial manufacturing.
Key Responsibilities
- Author and maintain design documentation including Design History Files (DHF)
- Support development of combination products / drug delivery systems across full lifecycle
- Apply design controls and ensure compliance with FDA, EU MDR, ISO 13485, ISO 14971
- Lead risk management activities including DFMEA, PFMEA, UFMEA
- Translate user needs into design outputs through Human Factors Engineering
- Support verification, specifications, packaging, and product development activities
Qualifications
- 5–10+ years in regulated medical device environment
- Strong experience with combination products / drug-device systems
- Expertise in design controls, DHF, and risk management (FMEA)
- Solid knowledge of cGxP, ISO 13485, ISO 14971, 21 CFR 820
- Bachelor’s or Master’s degree in Engineering or related field
- Strong technical writing and ability to manage multiple projects
