Biomedical Device Specialist

2 weeks ago


GondrecourtleChâteau, Grand Est, United States Collabera Full time
Senior Medical Device Engineer

We are seeking a highly skilled and experienced Senior Medical Device Engineer to contribute to the development of innovative medical technologies. The ideal candidate will have a strong background in development and design engineering, with an emphasis on quality assurance and regulatory compliance in the medical device industry.

Key Responsibilities:

  • Develop and design medical devices, collaborating closely with R&D teams.
  • Ensure compliance with applicable regulations, including 21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, and MDSAP.
  • Utilize quality tools and methodologies, with a preference for candidates experienced in Development Quality.
  • Drive cross-functional projects, demonstrating strong problem-solving and leadership skills.
  • Communicate effectively across multiple levels of the organization, ensuring alignment with cross-functional teams.
  • Multitask, prioritize, and meet deadlines while delivering high-quality work.
  • Occasionally travel to other local Minnesota sites (less than 5%).

Required Qualifications:

  • Bachelor's degree in Engineering or a closely related discipline (Mechanical or Biomedical Engineering degrees preferred, but not required).
  • 5-8+ years of Medical Device engineering experience, with demonstrated use of quality tools/methodologies.
  • Strong understanding of FDA, ISO, and international regulatory standards.
  • Excellent organizational, problem-solving, and communication skills.
  • Ability to work effectively in a highly matrixed and geographically diverse environment.
  • Capable of working both independently and as part of a team in a fast-paced environment.


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