Design Quality Engineer II

1 week ago

Minnetonka, Minnesota, United States Boston Scientific Full time $104,000 - $156,000 per year

Your responsibilities will include: Develops understanding of Design Controls, Risk Management and Usability for Medical Devices. Supports departmental, functional, and divisional design quality goals and priorities. Executes methodologies to effectively meet individual and team objectives. Bachelor of Science in Mechanical / Biomedical Engineering or related discipline in the sciences. Minimum of 2+ years experience in Design Quality Assurance, related experience in quality engineering or NPD design within a regulated industry Experience with medical device development for single use devices Working knowledge of key regulatory requirements, including ISO Risk Management), 21 CFR 820, 210, 211 (US QS Regulation), ISO Quality Management Systems), EU MDR, and IEC Usability). Understanding of Quality tools and methodologies with an emphasis on Design Controls, Root Cause Analysis and Risk Management. Strong communication skills (verbal & written) Ability to work independently and as part of a team. Ability to travel up to 10%. Comfortable with complaint data reviews and interpretation Experience with pharmaceutical or combination medical device development Experience with Electronic Medical Equipment.

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    10 hours ago

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    4 days ago

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    2 days ago

    Minnetonka, Minnesota, United States Laborie Medical Technologies Corp Full time

    We believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters – it's what fuels our motivation and contributes to our success. If you're ready to make a positive impact in the lives of patients across the globe, we'd like to meet you.   We support and empower our employees to grow their careers in...