Combination Product Development Engineer (Drug-Device Systems)

Combination Product Development Engineer (Drug-Device Systems) at JMD Technologies Inc. Combination Product Development Engineer (Drug-Device Systems) at JMD Technologies Inc. in North Providence, Rhode Island Posted in 1 day ago.

Type:

full-time

Job Description:

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