Senior Manager, Design Quality

Work Flexibility: Onsite

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

Travel Percentage: 10%

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.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.