Design Quality Engineer

1 day ago

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

At MPE we are dedicated to making a difference in the world through cutting-edge medical technology. Our mission is to be the global leader in design, engineering, and manufacturing solutions for the medical and technology industries. We are committed to creating impactful solutions that improve lives and fostering an environment where our team members can thrive, grow and contribute to groundbreaking advancements in the medical field.

A better career for you. Creating medical technology for all.

We are seeking a dedicated Design Quality Engineer to join our team. This critical role ensures that our products meet rigorous design and quality standards, aligning with regulatory requirements and enhancing patient safety. If you thrive in a dynamic, collaborative environment and are passionate about delivering high-quality medical devices, we want to hear from you

Key Responsibilities

  • Review and approve the translation of design input requirements into design output documents.
  • Evaluate and approve design verification/validation protocols and reports to ensure compliance with design input requirements.
  • Develop and apply statistical methods to verification, validation, and product inspection plans.
  • Maintain and enhance risk management, verification, and validation processes to support the Quality Management System.
  • Collaborate with project teams to establish and maintain Risk Management Files for products.
  • Identify and assess process/product hazards, probabilities, severities, and mitigations for Risk Analyses.
  • 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.
  • Monitor post-market data, including complaints, CAPAs, NCRs, and customer feedback, to update Risk Management Files.
  • Investigate, document, and resolve non-conformances, CAPAs, and customer complaints as needed.

Qualifications

Education:

  • Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical, or related field) or equivalent experience.

Experience and Training:

  • 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).

Why Join Us?

  • Mission-Driven Work: Be part of a team that creates impactful solutions in healthcare.
  • Growth Opportunities: We invest in your career through training and development.
  • Comprehensive Benefits:
    1. Medical (HSA-qualified plan and traditional plan available), dental, and vision coverage starting the first of the month after hire.
    2. 401K with company match.
    3. Nine paid holidays.
    4. Vacation time from day one.



Onsite only, no visa sponsorships or relocation available at this time.



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