Senior Design Assurance Engineer

1 day ago

Minneapolis, Minnesota, United States Custom Search Full time
Job Title: Senior Design Assurance Engineer

We are seeking a highly skilled Senior Design Assurance Engineer to join our team at Custom Search. As a key member of our medical device development project teams, you will be responsible for ensuring compliance to Design Controls requirements.

Key Responsibilities:
  • Lead quality activities and deliverables on cross-functional development teams.
  • Develop and implement strategic quality planning activities, including PMS planning.
  • Establish and maintain proper controls to meet or exceed internal and external requirements.
  • Collaborate with regulatory development project team members to summarize or generate information for regulatory agencies.
  • Utilize problem-solving methodologies to lead failure investigation activities and ensure root cause identification.
  • Lead design verification, design validation, usability, and test methods validation activities for new product development.
  • Coach and mentor product development teams on Design Control activities.
  • Drive consistent quality engineering practices among DA team members.
  • Ensure quality system compliance and primary team contact for audits.
Requirements:
  • BS or advanced degree in engineering or related discipline.
  • 5+ years overall medical device experience.
  • 5+ years experience in quality assurance or engineering function.
  • Expert knowledge of Design Control and Risk Management.
  • Knowledge of problem-solving methodologies and approaches.
  • Experience with Quality Systems as outlined in CFR820/ISO13485.
  • Experience with leading CAPA investigations and developing effective corrective actions.
  • Demonstrated technical expertise and leadership in quality.
  • Strong ability to communicate within and across disciplines and organizational structures.
  • Demonstrated use of Quality tools and methodologies.
  • Practical knowledge of applied statistics, including statistical analysis tools.
What We Offer:

Custom Search is a dynamic and innovative company that values its employees. We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.

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