Medical Device Design and Validation Expert

3 weeks ago


Milwaukee, Wisconsin, United States MPE-Inc Full time
Job Description

We are seeking a dedicated Design Quality Engineer to join our team. This role involves reviewing and approving design input requirements, evaluating design verification/validation protocols, and maintaining risk management processes.

Key Responsibilities:

  • Design, execute, and analyze validations for equipment, processes, and software.
  • Develop and validate test methods to support product evaluation.
  • Analyze and compile reports to support verification, validation, and engineering studies.
  • Evaluate the impact of equipment, design, and process changes on product quality, regulatory compliance, validation/verification, and risk profiles.
  • Support post-market surveillance through data analysis and reporting.

The estimated salary for this position is $90,000 - $115,000 per year. We are committed to creating impactful solutions that improve lives and fostering an environment where our team members can thrive.

Qualifications:

  • Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, or related field) or equivalent experience.
  • Minimum of three years of experience in design engineering or quality engineering within the medical device industry.
  • In-depth knowledge of FDA regulations (21 CFR Part 820, particularly Part 820.30 Design Controls and Part 820.40 Document Controls) and ISO 13485.
  • Experience with change control processes in a regulated environment.
  • Proficiency in risk management per ISO 14971.
  • Experience preparing technical files for medical devices.
  • Certified Quality Engineer (CQE) or Regulatory Affairs Certification (RAC).


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