Senior Production Engineer

4 weeks ago


WinstonSalem, United States The Resource Co Full time

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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