Senior Manager, Design Quality

Stryker • Irvine, CA

4d • Onsite

About The Position

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.

Requirements

• 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).

Nice To Haves

• 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

Responsibilities

• 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 This Job Offers

• Job Type: Full-time
• Career Level: Manager