Senior Production Engineer
4 weeks ago
Job Title: Senior R&D Production Engineer - Validation and Verification (Medical Device Manufacturing)
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.
Qualifications:
- 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.
Why Join Us:
Be part of a dynamic team driving innovation in medical devices while advancing your career in a supportive environment.
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