NPD Design Assurance Engineer
- Maple Grove, Minnesota
- Pharma & Biotech, Medical Devices, Engineering, Engineering & Validation, Regulatory Affairs, Quality Assurance (QA)
- Fulfill design assurance role on new product development (conception to launch) and sustaining projects
- Lead planning and execution of Design Controls, Risk Management, Test Method Development and Validation, Design Verification/Validation for new and existing products.
- Support Regulatory Affairs with creating submissions and responding to submission questions.
- Primary responsibility is New Product Development; secondary responsibility is Sustaining Engineering.
- Continued support and optimization of New Product Development deliverables and processes, accounting for cross functional system interactions.
- 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.
Sthree US is acting as an Employment Business in relation to this vacancy.