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Design Assurance Engineer - 246299

Design Assurance Engineer - 246299

MedixMinneapolis, MN, US
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Design Assurance Engineer (Direct Hire)

Location : Maple Grove, MN

Pay : $100K - $120K annually, based on experience

Qualifications :

  • Bachelor's degree in Engineering or a related discipline (Master's degree preferred).
  • Minimum of 5 years of experience in design assurance within the medical device industry.
  • Deep understanding of design controls and risk management principles under FDA and ISO guidelines.
  • Demonstrated experience with regulatory frameworks, including FDA 21 CFR 820, ISO 13485, and IEC 60601 or similar standards.
  • Proficient in statistical tools and software used for data analysis.
  • Strong communication skills and a collaborative approach to cross-functional teamwork.
  • Meticulous attention to detail and proven problem-solving capabilities.

Responsibilities :

  • Lead design assurance activities for new and existing product development projects, including design verification and validation efforts.
  • Develop and maintain design control and risk management documentation, such as DHF, DMR, and technical files.
  • Create and oversee test protocols and reports to ensure alignment with FDA, ISO, and IEC standards.
  • Analyze test results and prepare high-quality technical documentation for regulatory submissions.
  • Facilitate design reviews and provide strategic input to enhance product quality and safety.
  • Monitor evolving regulatory requirements and industry trends to drive continuous improvement in design assurance practices.
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    Design Engineer • Minneapolis, MN, US

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