Stryker - Inari Medical (https://www.inarimedical.com/) is hiring a **Staff Engineer, Design Quality** in **Irvine** , **California** ! In this role, you will partner with Engineering and Advanced Operations to define design requirements and develop manufacturing processes that support new product development projects. You will also lead risk management activities to ensure the highest level of product and process quality! **What You Will Do:** + Develop quality documentation to support new product development and regulatory submissions. + Maintain and improve quality systems by identifying and correcting procedural deficiencies. + Lead risk management activities and present final risk/benefit justifications to leadership. + Drive product and process design activities in cross-functional teams. + Define and validate design verification and validation (V&V) test requirements and methods. + Present product risks during design reviews and ensure mitigation through development. + Support manufacturing process development and product design transfer to internal/external sites. + Apply statistical analysis and problem-solving techniques to define acceptance criteria and resolve quality issues. + Review and approve inspection plans, routers, and product drawings. + Evaluate predicate devices and define critical quality attributes through risk analysis. + Contribute to final V&V reports with statistically valid conclusions and graphical summaries. + Support early market feedback collection and resolution of initial product concerns. **What You Need:** **Required:** + Bachelor’s degree in science, engineering or related discipline. + 4+ years’ related experience required. + Medical device industry experience required. + Familiarity with New Product Development (NPD) processes and/or involvement in cross-functional activities supporting product development and commercialization. **Preferred:** + MS, CQE, or CRE preferred. + Six Sigma Green or Black belts are preferred. + Experience with the medical device development lifecycle, including risk management and design/process verification and validation. + Proficient in quality tools such as FMEA, GD&T, root cause analysis, and Poka-Yoke, as well as core quality concepts. + Proficient in data analysis tools (e.g., Minitab) and interpreting CAD drawings to support design and process evaluations. + Proven project management and cross-functional collaboration skills. + Excellent communication, problem-solving, and analytical abilities. $100,700.00 - $165,100 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors. Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role. Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.