Senior R&D Engineer (CONTRACT)
4900 Bethania Station Road Winston Salem, NC 27105 US
Job Description
Location: Winston-Salem, NC
Job Summary:
Seeking a skilled Senior R&D Engineer with expertise in Validation and Verification (V&V) for medical device manufacturing. You’ll lead V&V activities to ensure compliance with FDA, ISO, and other regulatory standards, working closely with design, quality, regulatory, and manufacturing teams.
Key Responsibilities:
- Lead V&V activities, including test plans, protocols, and data analysis, ensuring regulatory compliance.
- Collaborate with design engineers to develop testable product requirements and support risk assessments.
- Prepare and review documentation for regulatory submissions (DHF, Technical Files).
- Support manufacturing teams in process validation and resolve V&V issues during production.
- Drive continuous improvement initiatives and mentor junior engineers.
- Bachelor’s or Master’s in Biomedical Engineering, Material Science, or related field.
- 5+ years in R&D with a focus on V&V in the medical device industry.
- Strong knowledge of V&V methodologies, FDA and ISO standards, and statistical analysis.
- Experience with risk management and software validation (if applicable).
- Preferred: Experience with SaMD, Six Sigma, or CQE certification.
Be part of a dynamic team driving innovation in medical devices while advancing your career in a supportive environment.
Reach out to Jordan today for more information about this opportunity.
Meet Your Recruiter
Jordan Milligan
Jordan is a Direct-Hire Recruiter at The Resource, with experience in all aspects of the recruiting process from sourcing to closing. He's passionate about helping companies find their next great hire, and takes pride in helping candidates advance their careers.
Jordan would love to hear from you if you're looking for a new opportunity or have a job opening at your company that needs to be filled quickly. Be sure to connect with him on LinkedIn too!
Hobby: Playing guitar, Favorite getaway: The Outer Banks, Favorite Childhood Book: Lemony Snicket's "A Series of Unfortunate Events" (as a kid, I read every single book in this series multiple times), Favorite Band: Toto, All-time Favorite Vacation Destination: Barcelona, Spain