Product Development Engineer
Job in
Winston-Salem, Forsyth County, North Carolina, 27104, USA
Listed on 2026-08-29
Listing for:
Staftonic LLC
Full Time
position Listed on 2026-08-29
Job specializations:
-
Engineering
Biomedical Engineer, Product Engineer, Quality Engineering, Manufacturing Engineer
Job Description & How to Apply Below
- Lead product/design changes from feasibility and prototyping through design verification (DV) and manufacturing implementation.
- Apply Design Controls, DHF, Risk Management, and FMEA throughout the product development lifecycle.
- Develop, validate, and execute test methods, simulated-use testing, and verification protocols.
- Support and execute IQ/OQ/PQ activities as applicable.
- Create and maintain engineering drawings, specifications, test protocols, reports, and other technical documentation.
- Work directly on the manufacturing floor and in the laboratory to troubleshoot product and process issues.
- Collaborate with manufacturing, quality, R&D, and engineering teams to resolve technical issues and implement design improvements.
- Communicate project status, technical risks, engineering decisions, and recommendations to engineering stakeholders.
- Provide technical direction and review work performed by an offshore engineering team.
- 5–7+ years of hands-on medical device engineering/product development experience.
- Strong experience with medical device design and development in a regulated environment.
- Experience taking design changes from concept/prototype through verification and production.
- Strong knowledge of design controls, DHF, risk management, FMEA, and design verification.
- Experience developing and validating engineering test methods.
- Experience with simulated-use testing and verification testing.
- Familiarity with IQ/OQ/PQ and validation protocols.
- Ability to create, interpret, and maintain engineering drawings, specifications, and technical documentation.
- Strong troubleshooting and problem-solving skills with the ability to work directly with manufacturing and laboratory teams.
- Catheter-based medical devices
- Compliant balloon catheters
- Biopsy needles
- Interventional or minimally invasive medical devices
- Catheter assemblies, delivery systems, guide wires, or similar devices
- Design transfer and manufacturing implementation
- DFM / Design for Manufacturing
- CAD tools such as Solid Works or Creo
- Experience providing technical guidance to offshore engineering teams
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