Manager, Quality Engineering at Stryker

Irvine, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

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

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
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

Skills

Design Control

FMEA

Risk Management

ISO 13485

FDA 21 CFR 820

New Product Development

Quality Engineering

Regulatory Compliance

Project Management

Stryker

Develops and manufactures medical devices and equipment

About Stryker

Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.

Kalamazoo, MichiganHeadquarters

1941Year Founded

$423.3MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Medical & prescription plans

Supplemental health benefits

Flexible Spending accounts

Employee Assistance Program

Short-term & long-term disability

Tuition reimbursement

401(k) plan

Employee Stock Purchase Plan

Risks

Integration challenges from acquisitions may strain Stryker's resources.

Rapid tech advancements risk obsolescence of Stryker's current products.

Regulatory scrutiny on acquisitions could delay Stryker's market entry.

Differentiation

Stryker's acquisitions enhance its minimally invasive surgical solutions portfolio.

Entry into the peripheral vascular segment diversifies Stryker's market presence.

Stryker's focus on AI integration boosts diagnostic accuracy and operational efficiency.

Upsides

Growing demand for minimally invasive solutions aligns with Stryker's strategic acquisitions.

The orthopedic implants market growth benefits Stryker's expanding product line.

Stryker's acquisition of Inari Medical positions it in a high-growth vascular market.

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