Biomedical Engineer
4 weeks ago
We are seeking a highly skilled and experienced Senior Medical Device Engineer to join our team. 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. You will collaborate cross-functionally, particularly with R&D, to contribute to the development of innovative medical technologies. Local candidates are required for this hybrid role, which includes up to 2 days off-site and occasional travel to local sites.
Key Responsibilities:
- Engage in the development and design of medical devices, working closely with R&D teams.
- Ensure compliance with applicable regulations such as 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.
- Demonstrate strong problem-solving and leadership skills to drive cross-functional projects.
- 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 (21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, MDSAP).
- 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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