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Senior R&D Engineer – Peripheral Vascular Health
Company | Medtronic |
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Location | Wayzata, MN, USA |
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Salary | $104000 – $156000 |
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Type | Full-Time |
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Degrees | Bachelor’s, Master’s |
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Experience Level | Senior |
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Requirements
- Bachelor’s degree in engineering (preferably Mechanical, Biomedical, Electrical or related field)
- Minimum of 4 years of R&D engineering experience
- OR Advanced degree with 2 years R&D engineering experience
Responsibilities
- Collaborate with cross-functional teams to refine and optimize the product design based on Phase 2 feedback, ensuring manufacturability, usability, and performance standards are met.
- Lead efforts to develop, execute, and document verification and validation protocols, ensuring the product meets design inputs and complies with regulatory requirements. Participate in preclinical evaluations.
- Perform detailed risk assessments (e.g., DFMEA) and implement mitigation strategies to address potential design and process risks.
- Partner with Regulatory Affairs to ensure the product meets applicable global medical device standards (e.g., FDA, ISO, EU MDR).
- Work closely with Quality, Manufacturing, and Marketing teams to support product transfer into production, ensuring alignment with customer and business needs.
- Participate in technical design reviews, providing expertise to address technical challenges and ensure robust product performance.
- Generate and review technical documentation, including engineering drawings, test protocols, and reports, to ensure compliance with Medtronic’s quality systems and regulatory standards.
- Provide guidance and mentorship to junior engineers, fostering a culture of innovation, collaboration, and continuous improvement.
Preferred Qualifications
- Experience in the medical device industry
- Proficiency in design tools (e.g., CAD software) and analysis methods.
- Strong understanding of medical device design controls, PDP processes, and regulatory requirements.
- Experience with verification and validation testing, including familiarity with statistical methods and tools.
- Understanding and wide application of technical principles, theories and concepts in the field.
- Strong problem-solving and analytical skills.
- Excellent communication and collaboration abilities.
- Proven leadership skills, with the ability to influence and drive results in a cross-functional team environment.