Principle Design Assurance Engineer
- Maple Grove, Minnesota
- Pharma & Biotech, Medical Devices, Engineering, Engineering & Validation, Quality Assurance (QA), Quality Assurance (QA), Risk
Are you looking for an opportunity to do meaningful work that changes lives? Become a part of an team that is trusted partners of medical clinicians and the patients they serve. Offer practical solutions that build, nurture, and strengthen the vital parts at the heart of healthcare. We strive to improve the health and quality of people's lives. I am currently looking for a Principle Design Assurance Engineer in our Maple Grove location.
In this role, as a Principle Design Assurance Engineer you will fulfil design assurance on New Product development (conception to launch) and sustaining projects. You will lead planning and execution of Design Controls, Risk Management, Test Method Development and Validation, Design Verification/Validation for new and existing products.
Responsibilities are as follows:
- Participate and lead New Product Development Phase Reviews and Design Reviews.
- Partner with R&D to determine and define design inputs, design outputs, and design input/output relationships.
- Create and support the development and validation of new test methods.
- Determine and document risks associated with the product (Hazard Analysis, DFMEA, PFMEA, UFMEA).
- Develop the strategy and manage the execution of design verification and validation.
- Generate test protocols, manage test execution, investigate test issues, analyze data, and create reports for design verification and validation testing.
- Develop, execute, and manage First Article inspections.
- Support regulatory approvals and responses to regulatory questions.
- Support Sustaining Engineering for design and process changes to commercialized product.
- Manage a team of design assurance engineering technicians - including mentoring, training, assigning tasks, and providing work direction.
- Provide direction to design assurance engineering technicians supporting assigned projects.
- Review and improve design assurance specific quality system deliverables and processes to increase effectivity and efficiency.
- Support the transfer of new product development projects from development to production.
- Support internal and external audits - including preparation and direct interaction with auditors.
- Helping to develop test methods and validate those methods
- Mapping out the design outputs that control those design inputs
- R&D staff is very smart technically - can partner with them, help refine and improve design and processes
Sthree US is acting as an Employment Business in relation to this vacancy.