Lead Development Engineer; Combination Drug Devices
Job in
Town of Poland, Jamestown, Chautauqua County, New York, 14701, USA
Listed on 2026-07-15
Listing for:
RBW Consulting
Full Time
position Listed on 2026-07-15
Job specializations:
-
Manufacturing / Production
Regulatory Compliance Specialist, Medical Device Industry
Job Description & How to Apply Below
Location: Town of Poland
Poland preferred - other EU countries in Eastern/Central Europe may also be relevant
We’re partnered with a highly regarded, innovation‑led pharma organisation looking to hire a Lead Engineer to support the development of combination products at the interface of drug delivery and medical device engineering.
This is a key role for someone who enjoys owning technical development, coordinating cross‑functional teams, and working within complex regulatory environments.
The Role- Lead engineering activities across drug‑device combination product development
- Drive integration of device + formulation, ensuring performance and compliance
- Own and deliver technical documentation (protocols, reports, design files) in line with regulatory standards
- Ensure compliance with MDR, ISO
13485, and 21 CFR Part 4 - Act as key interface across QA, QC, Regulatory, and formulation teams
- Manage and coordinate external partners and development collaborators
- Strong experience in medical device development and/or packaging engineering
- Background in combination products or regulated device environments is highly advantageous
- Proven project leadership / coordination experience
- Opportunity to work on complex combination products within an established pharma environment
- Strong cross‑functional exposure across device, formulation, and regulatory
- Long‑term, stable business with continued investment in innovation
- Flexible working and competitive benefits package
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