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Principal Research & Development Engineer

EPM Scientific
Minneapolis, MN Full Time
POSTED ON 2/25/2025
AVAILABLE BEFORE 5/18/2025

Job Summary :

The Principal R&D Engineer will lead the design, development, and commercialization of Class III medical devices, ensuring technical excellence and regulatory compliance. This role requires expertise in product development, risk management, and cross-functional collaboration to drive innovative solutions from concept to market.

Key Responsibilities :

  • Lead design, development, and validation of Class III medical devices.
  • Drive innovation through advanced engineering principles and problem-solving.
  • Develop and execute design control documentation per regulatory standards (ISO 13485, FDA 21 CFR 820).
  • Perform risk assessments (DFMEA, PFMEA) and ensure product safety.
  • Collaborate with cross-functional teams, including regulatory, quality, and manufacturing.
  • Support verification, validation, and transfer to manufacturing.
  • Stay updated on industry trends and emerging technologies.

Qualifications :

  • Bachelor’s / Master’s in Mechanical, Biomedical, or related engineering field.
  • 8 years of experience in medical device R&D, preferably Class III.
  • Expertise in design controls, risk management, and product lifecycle.
  • Strong knowledge of regulatory standards (FDA, ISO 13485, MDR).
  • Proficiency in CAD, FEA, and prototyping techniques.
  • Excellent problem-solving and leadership skills.
  • Apply now to be a part of cutting-edge medical innovation!

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