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Senior Design Quality Assurance Engineer

2 months ago

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

TransMedics, Inc. is a pioneering company in the field of organ care, revolutionizing the way organs are preserved and transplanted. We are seeking a highly skilled Senior Design Quality Engineer to join our team and contribute to the development of our innovative Organ Care System (OCS).

Key Responsibilities:

  • Lead the design quality engineering functions in support of product development, ensuring compliance with regulatory requirements and customer expectations.
  • Partner with development and engineering departments to ensure effective design control processes, achieving quality by design.
  • Review and approve design control related Change Notices (CNs) within the documentation system.
  • Develop and implement processes to ensure consistent implementation of internal requirements and external regulations and standards.
  • Represent the design quality functions for the review and approval of designated design outputs.

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.

What We Offer:

TransMedics, Inc. offers a dynamic and challenging work environment, opportunities for professional growth and development, and a competitive compensation package.