Principal Research & Development Engineer
EPM Scientific - Minneapolis, MN
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Job **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 *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.****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!
Created: 2025-02-19