Principal Design Quality Engineer

Role overview Lead design quality engineering for new product development and product changes in a regulated medical-device environment. The position works with engineering and product teams to build quality into development, manage risk, support verification and validation, and maintain compliance records. It also contributes to continuous improvement, audit readiness, and the development of less experienced quality engineers.

Responsibilities - Guide product teams on design controls and quality system requirements related to applicable regulations and standards. - Manage project quality plans and help translate customer needs into development requirements and engineering specifications. - Lead or review risk management work, including hazard analyses, risk plans and reports, FMEAs, and fault tree analyses. - Support development plans, test plans, verification and validation protocols and reports, and traceability between requirements and test evidence. - Define statistical sampling and measurement system analysis; review failure data and share findings with development teams. - Maintain design and manufacturing records, mentor quality engineers, support audits, and lead continuous improvement activities.

Requirements - Bachelor’s degree in engineering, such as electrical, biomedical, or mechanical engineering, or an equivalent technical discipline. - At least 8 years in a medical device or comparable regulated environment, including 8 years in design quality engineering or equivalent design work. - Professional certification as a Quality Engineer, Reliability Engineer, or Six Sigma Black Belt. - Experience with design controls, risk management, verification and validation, and quality system processes. - Ability to work across product portfolios and partner with engineering and other functions on product development and changes.

Benefits and work setup The listed annual base pay range is $103,600–$176,400, with possible discretionary bonus and long-term incentive eligibility depending on the role. Benefits may include retirement plan matching, stock purchase participation, flexible time off or accrued vacation, paid sick leave, holidays, parental leave, disability coverage, tuition reimbursement, and health benefits. Applicants must already be authorized to work in the United States; visa sponsorship is not available.