Design Assurance Engineer III

Job Overview Design Assurance EngineerIII – Plymouth, MN Responsibilities Adhere to Integer values and safety and quality requirements (QMS, EMS, FDA regulations, company policies). Participate in development project teams and perform quality/reliability engineering activities to ensure design/development procedures, design controls, supplier controls and test requirements are fulfilled. Lead Risk Management (ISO14971) activities, including planning, analysis (DFMEA, FTA, Risk/Benefit) and mitigations; maintain risk management file throughout the device life cycle. Generate and review design verification and validation protocols and reports, process validation protocols and reports. Coordinate with R&D on reviewing technical documentation and with Product Development Manufacturing Engineering on test fixture development, production acceptance criteria and test methodology. Coordinate sourced item qualification activities and support supplier risk management initiatives. Conduct independent reviews of DHF and technical files, interpret technical standards, determine appropriate statistical methods, including sample size determination. Support root‑cause analysis, CAPA preparation and Distributed Product Risk Assessment. Draft and update SOPs as required. Qualifications Bachelor’s degree in Mechanical Engineering or related field with 5years of experience, or Master’s degree in Mechanical Engineering or related field with 3years of experience. 5years of experience (or 3years with Master’s) in quality Lean‑Sigma tools (RootCause Analysis, QFD, Ishikawa, KepnerTregoe), Gage Repeatability and Reliability studies, Attribute Agreement Analysis, sourced‑item qualification, and non‑conforming material investigations. 4years of experience (or 2years with Master’s) in creating risk management files per ISO14971 for Class2 or3 devices under EU MDR2017 or 510K FDA submissions, and performing design verification and validation for such devices. U.S. work authorization required. Benefits Competitive base salary and cash‑based incentive program. Health, dental, vision, disability, life insurance and adoption benefits. Parental leave after one year of employment. 401(k) plan with company matching. 10 days (80hours) company designated holidays plus paid time off. EEO Statement Integer is an equal‑opportunity employer. We do not discriminate based on race, color, sex, religion, national origin, veteran status, disability or any other protected characteristic. Integer welcomes veterans and individuals with disabilities and places a strong emphasis on diversity and inclusion. Ref #14057 #J-18808-Ljbffr Integer Holdings Corporation