Manager, Quality Engineering

Manager, Quality Engineering

Join a team where innovation meets impact! Stryker Inari Medical is hiring a Manager, Quality Engineering in Irvine, California! In this role, you'll lead and mentor a 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!

This is an onsite position with the option to work remotely one day per week.

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.

• Make independent decisions on projects, programs, and portfolio-level challenges to drive successful outcomes and support business strategy.

• Mentor and develop team members by translating department goals into clear performance objectives and providing actionable feedback.

• Influence cross-functional collaboration by building strong relationships across technical teams and business unitsincluding Regulatory Affairs, Quality, Marketing, Clinical, Operations, and Financeto drive innovation and alignment.

• 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 applicable technical discipline.

• 8+ years of experience in engineering or a related technical field.

• Experience in the medical device industry.

• 3+ years of direct people management experience.

Preferred Qualifications

• Experience across the entire product lifecycle.

• Experience mentoring in one or more technical or functional disciplines.

• Proven ability to deliver programs on time, within budget, and to quality standards.

• General knowledge of the healthcare market and competitive landscape.

• Experience executing talent and performance management strategies.

• Demonstrated ability to communicate complex technical plans across teams and leadership levels.

$132,900 - $217,500 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.