Principal Engineer, Quality

As a Principal Engineer, Product Quality, you will ensure the establishment and execution of world-class Design Control processes that deliver safe and reliable products, while also enabling speed to market. You will partner with the Sustaining Engineering team in the design maintenance of FDA Class I and Class II medical devices to ensure that design control principles are followed, and that safety & efficacy are demonstrated. At all times throughout the process, you will identify and mitigate risks. Your team is dedicated to quality. Delivering life-saving products is about getting them right, and our technical expertise and experience working in a manufacturing environment empower us to meet that challenge. What you'll be doing includes providing quality assurance support and oversight for product design activities, ensuring compilation and maintenance of product Design History Files, partnering with Sustaining Engineering and Research & Development, reviewing and approving Design Verification and Validation test plans, documenting traceability of requirements, participating with design teams on developing product Risk Management Files, supporting external regulatory and customer audits, and collaborating with global Design Assurance team to drive continuous improvement.