Staff Design Quality Engineer

Why engineering at Stryker?

At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products.  You will also have growth opportunities as we have a culture that supports your personal and professional development.

Need another reason to apply? Check out these 8 reasons to join Stryker’s engineering team:  

We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting 

Staff Design Quality Engineer (Hybrid)

Stryker is hiring a Staff Design Quality Engineer in Redmond-WA, to support our Medical Business. You will work as the Design Quality partner within a cross-functional product development team to enable timely launch of the highest quality products that meets and exceeds customer and stakeholder expectations in support of a successful product lifecycle of a medical device. You will serve as a representative for the Quality Management System at all times and drive continuous process improvement.

Who we want

• Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, efficiency, change, and outcomes.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.
• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

What you will do

• Participate in the new product development process by ensuring that all the quality data streams are fully comprehended and that the voice of the customer, as heard through these data streams (complaints, non-conforming records, verified failures, etc.), is a design input and consideration.
• Lead product safety Risk Management activities, including characterization of design risks, which includes both the appropriate risk control activities and proper identification in downstream design outputs. Develop Risk Management File deliverables including Product Hazard Analysis, design failure modes and effects analysis [DFMEA], Critical to Quality characteristics on specifications, Risk Assessments for issues impacting distributed product, etc..
• Develop validation strategies for new projects that are consistent with design validation policies and procedures. Provide technical direction and approval of validation plans, protocols, reports.
• Provide technical direction in optimization of test plans, test methods, and sampling.
• Identify the appropriate field performance trending metrics, establishing standardized reporting mechanisms, analyzing results to identify emerging trends and improvement opportunities, and reporting for production and post-production monitoring of new products after launch.
• Provide Quality leadership to drive the timely resolution of quality issues impacting assigned product lines and participate in the CAPA process as necessary. Advise on risk management investigations for HHE, PFAs, NCs and CAPAs or other post-market issues as needed.
• Participate in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of product development within the Design Controls process.
• Provides mentorship to other members of the quality engineering team. Offers coaching and support to the quality team and other business functions on quality topics and activities at an expert level.

What you need

Basic Qualifications:

• Bachelors Degree
• 4+ years of experience working in a highly regulated environment, quality, manufacturing, or engineering.

Preferred Qualifications:

• Bachelors Degree in Biomedical Engineering
• Expert in medical device industry policies and regulations.
• Prior experience working with electro-mechanical devices and embedded software in a product development capacity.
• General statistical quality tools knowledge with process capability; demonstrated ability to apply six sigma and statistical quality control methodologies.
• Knowledge of quality tools for process capability, root cause investigation, developing sampling plans, test method validation, or other Quality tasks
• Knowledge of good design practices, specification development, industry standards, etc.

$98,300.00 – $161,100.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

About Stryker

Our benefits:

• 12 paid holidays annually

• 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.

For a more detailed overview of our benefits or time off, please follow this link to learn more:  US Stryker employee benefits

About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company 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 130 million patients annually. More information is available at  stryker.com.

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Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.