Senior R&D Engineer
Job in
Winston-Salem, Forsyth County, North Carolina, 27104, USA
Listed on 2026-09-25
Listing for:
Staftonic LLC
Full Time
position Listed on 2026-09-25
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer, Product Engineer, Test Engineer
Job Description & How to Apply Below
- Lead product and design changes from feasibility and prototyping through Design Verification (DV) and manufacturing implementation.
- Apply design controls, risk management, and structured engineering documentation throughout the product lifecycle.
- Develop, validate, and execute engineering test methods, including simulated-use testing
. - Develop and execute IQ/OQ/PQ protocols as required.
- Create and maintain engineering drawings, specifications, DHF documentation, and other technical records.
- Support troubleshooting and root-cause investigations on the manufacturing floor and in the laboratory
. - Communicate technical decisions, project status, risks, and issues to engineering stakeholders.
- Provide technical direction and review work performed by an offshore engineering team.
- Collaborate with Engineering, Quality, Manufacturing, Regulatory, and other cross-functional teams.
- Experience in medical device product development or R&D engineering
. - Strong knowledge of design controls, DHF, risk management, and design verification/validation
. - Experience developing and executing engineering test protocols and test methods.
- Familiarity with IQ/OQ/PQ and simulated-use testing
. - Ability to create and interpret engineering drawings, specifications, and technical documentation.
- Strong problem-solving and root-cause analysis skills.
- Comfortable working hands-on in both laboratory and manufacturing environments
. - Strong communication and cross-functional collaboration skills.
- Catheter-based or minimally invasive medical devices
- Compliant balloon catheters
- Biopsy needles
- Design transfer / manufacturing implementation
- Technical leadership or experience guiding engineering teams
Position Requirements
10+ Years
work experience
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