Stryker is hiring a **Senior** **Manager, Design Quality** in **Irvine, California** ! In this role, you’ll lead a sizable, high-performing team of Design Quality Engineers, who are shaping the future of medical technology. You’ll guide and support their efforts on high-impact **new product development** ( **NPD** ) projects, ensuring design requirements are met and manufacturing processes are optimized to deliver life-changing solutions to patients! **What You Will Do:** + **Drive talent strategy** by attracting, developing, and retaining top engineering talent while fostering a culture of growth and high performance. + **Lead high-complexity projects** from concept to execution, managing budgets, timelines, and staffing to meet business goals. + **Ensure technical excellence** by overseeing design control activities for new and existing products and processes, guiding teams through risk management (e.g., FMEA), and reviewing or delegating approval of regulatory documentation in compliance with FDA 21 CFR Part 820 and ISO 13485. + **Lead** **continuous improvement initiatives** to enhance quality system effectiveness, productivity, and cost efficiency across engineering processes. + **Drive achievement** of key engineering and quality metrics, including product quality performance, on time design deliverables, and timely closure of NC/CAPA actions. + **Influence cross-functional collaboration** with Regulatory, Marketing, Clinical, Operations, and Finance teams to align technical strategies with business goals and customer needs. + **Partner with customers and key opinion leaders (KOLs)** to develop technical strategies that align with clinical and business needs. + **Contribute to financial strategy** by managing project-level budgets and supporting broader R&D financial planning. **What You Will Need:** **Required Qualifications** + Bachelor’s degree in engineering or a related technical discipline. + **Minimum 10 years of experience** in engineering or a related technical field. + Experience in the **medical device industry.** + **Minimum 5 years of people management experience.** + Strong knowledge of **design controls, risk management, test method validation,** and **quality concepts** (including CAPA, audits, and statistics). **Preferred Qualifications** + Advanced degree (MS or PhD) in engineering or a related technical field. + Certifications such as Six Sigma Black Belt, ASQ CQE, or ASQ CRE. + Experience with full lifecycle medical device development from concept through launch. + Experience executing talent development and performance management strategies. + Experience working in complex compliance or risk‑based environments $155,900.00 - $259,800 salary plus bonus eligible + benefits. 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.