Senior Engineer, Design Assurance Engineering Sustaining

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 

Senior Engineer, Design Assurance Engineering Sustaining (Hybrid)

Stryker is hiring a Senior Design Assurance Engineer in Mahwah, NJ, OR Weston Florida, OR Kalamazoo MI to support our Joint Replacement business.

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

As a Senior Design Assurance Engineer, you will lead Sustaining Quality Engineering activities in the maintenance of orthopedic products to ensure the highest level of product quality. Senior Design Assurance Engineers efficiently drive  rigor in Sustaining activities through creative  problem solving and ensure market continuity of  safe and  effective products. Being a part of this team means that you are working cross functionally to drive our company’s mission and strengthen the Stryker brand.

You will also provide guidance to and work with Product Development, Regulatory Affairs, and Manufacturing/Operations to ensure compliance to the company’s quality system and external standards.

• Work closely with the Product Development team to ensure that product designs meet quality requirements such as safety, effectiveness.
• Lead risk management activities for existing portfolios by developing risk management plans, conducting risk reviews, verifying implementation and effectiveness of risk controls.
• Ensure compliance to Stryker’s Procedures as well as all other product specific standards/regulations and guide teams as necessary.

What you need

Required Qualifications

• Bachelor’s degree in engineering (Biomedical/mechanical) or a related scientific discipline required.
• 2+ years of work experience.

Preferred Qualifications

• Experience in a strongly regulated environment such as medical device, military or aerospace industry.
• Previous experience in data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues.
• Experience within medical device product development life cycle, which include risk management, usability engineering and/or design/ process verification & validation.
• Knowledge of FDA QSRs, ISO 13485 Design Control Procedures and ISO 14971.
• Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poka Yoke.
• Demonstrated ability to effectively work cross functionally with other departments including Operations, Product Development, Regulatory and Marketing. 
• Demonstrated ability to read and interpret CAD drawings.
• NC/CAPA experience.

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.

Know someone at Stryker?
Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program on our  referral page

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.