Product Development Engineer II
$70,500–$103,400 year
On-site · Clarence, New York, United States
Job Summary
Design and development of new medical device products and manufacturing processes from concept to commercial production. Collaborate with cross-functional teams to plan and execute design engineering activities, develop and review drawings and specifications, plan testing, perform failure analysis, and prepare required documentation while ensuring adherence to QMS and FDA/regulatory requirements. Requires a bachelor’s degree in engineering and at least three years of relevant experience (candidates with 7+ years considered as well).
Required Qualifications
- Bachelor’s degree in engineering or related technical field
- at least three years of relevant experience
- ability to work independently and with cross-functional teams
- knowledge of Quality Management Systems (QMS) and FDA regulations
- ability to develop and review test procedures, plans, and documentation
- experience with design and development of products and processes from concept to manufacturing
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