Senior Design Quality Assurance Engineer

6 days ago


Andover, Massachusetts, United States TransMedics Full time
Job Title: Senior Design Quality Engineer

TransMedics, Inc., a pioneering company in organ care, is seeking a highly skilled Senior Design Quality Engineer to join their team. The company is revolutionizing organ preservation and optimization, aiming to increase transplant volumes and make more organs available worldwide.

Key Responsibilities:

  • Ensure the overall health of the design control process.
  • Partner with Development and Engineering departments to meet customer expectations and regulatory requirements.
  • Provide input to design and manufacturing engineering project deliverables.
  • Review and approve design control related Change Notices.
  • Create processes and process improvements to ensure consistent implementation of internal requirements and external regulations.

Requirements:

  • BS in Engineering with 8+ years of related experience or equivalent combination of education and experience.
  • Medical device development control experience required.
  • Working knowledge of Software development lifecycle desired.
  • Working knowledge and practical application of 21 CFR Part 820, ISO 13485, ISO 14971.
  • Practical knowledge and experience using Minitab or other statistical analysis tools.

Education:

BS in Engineering or other technical discipline.



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