What are the responsibilities and job description for the Senior NPI Engineer position at Cypress HCM?
A medical device manufacturing client is looking to add to their team onsite in Maplewood, Minnesota. This Senior New Product Introduction Engineer will lead the technical execution of qualification, validation, and transfer-to-production activities for new medical device products. This role provides engineering leadership, advanced statistical expertise, and cross-functional coordination to ensure new designs are robust, scalable, and compliant with regulatory and quality system requirements.
Skills Needed
Skills Needed
- Bachelor’s degree in Mechanical, Industrial, Biomedical, or related Engineering field
- 8 or more years of experience in catheter or medical device development, manufacturing, or validation
- Strong expertise in IQ/OQ/PQ and statistical analysis
- Excellent working knowledge of GD&T, SolidWorks, and MiniTab
- Strong understanding of medical device design and manufacturing processes
- Experience with design controls, FDA regulations, GMP, GDP, and QMS
- Ability to work with microscopes and sit/stand for extended periods of time
Salary : $110,000 - $143,000