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Manager, Quality Engineering

Stryker

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Stryker

Manager, Quality Engineering

Onsite Irvine, CA, United States Full Time Senior
Posted a month ago
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Job Details

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 units—including Regulatory Affairs, Quality, Marketing, Clinical, Operations, and Finance—to 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.

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.
Required Skills
  • Quality Engineering
  • NPD (New Product Development)
  • Design Control
  • Risk Management
  • FDA Regulations
  • ISO 13485
Company Details
Stryker
 Kalamazoo, MI, United States
Work at Stryker

Stryker is a global leader in medical technologies and, together with our customers, we are driven to make healthcare better. We offer innovative... Read more

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