Job Title: Design Quality EngineerDuration: 12+ Months (Possible extension)Location: Maple Grove, MN 55311Hybrid RoleResponsibilities:- Imaging diagnostic catheter design changes
- Working with a team of 5 Design Assurance engineers
- The Design Quality Engineer will support the application of design controls to projects focusing on design changes, material continuity, regulatory and standards compliance, corrective and preventive actions, and improvements for manufacturability and cost reduction.
- This individual will work with a cross-functional team to ensure safety, quality, and compliance of products.
- Ownership of design change projects including scoping, assessment, and implementation.
- Develop, update, and maintain Design History File and Design Input / Output documentation
- Develop, update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA.
- Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements.
- Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Education/Experience:- Bachelor's degree in an engineering discipline
- Experience in design assurance, quality, or related medical device or regulated industry experience
- 5 - 7 Years experience with BS, 3 - 5 Years with MS
- Medical device experience preferred
- Must have worked in a regulated space
- Design quality experience, Design assurance experience
- Risk management experience