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Staff Quality Engineer, Design Assurance NPD - Human Factors (R456083)

Human Resources

Human Resources Assistant



Mahwah, New Jersey, United States

COVID-19 vaccination requirements

Stryker is driven to work together with our customers to make healthcare better. In order to fulfill our commitment as a federal contractor, while focusing on the health and safety of our employees and those that we serve, COVID-19 vaccines will be required for all Stryker US employees effective January 4, 2022, as well as all new US employees joining our company. Fully vaccinated persons are those who are >=14 days post-completion of the primary series of an FDA-authorized COVID-19 vaccine. If you are applying to a sales and field role which requires access to customer accounts as a function of your job, you may be required, depending on customer requirements, to obtain the COVID-19 vaccination before the January 4 effective date of Stryker's vaccine policy. For more information, please visit our COVID-19 Vaccination Requirements FAQs page.

Why join Stryker?

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

Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.

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:

Who We Want

We are looking for a driven and detail oriented individual that has a passion for Quality and New Product Development. We need you to be an advocate for integrating quality into our innovative designs.
You will be joining a team of self-motivated, independent and creative thinkers, we work together and across function ensuring product excellence.
Our team works within the Design Assurance function but your role will have significant interaction with PD, Marketing and Operations.

What you will do
As a Staff Quality Engineer, Design Assurance you will lead design control activities, human factors/usability engineering and risk management processes throughout the new product development process. You will formulate and analyze both qualitative and quantitative usability test data as well as observe users in simulated environments, especially for interactions and participants' body language. Being a part of this team means that you are working cross functionally to drive our companies mission and strengthen the Stryker brand. You should love solving novel problems in fast paced and stimulating environment.

What you need

  • Minimum of 5+ years’ experience in human factors engineering support ideally in a strongly regulated environment such as medical device, military or aerospace industry
  • Bachelor’s Degree in Mechanical Engineering, Human Factors Engineering, Industrial Design, or related engineering science
  • Leadership experience in risk management activities for new product development teams by developing risk management plans and reports, conducting risk reviews, verifying implementation and effectiveness of risk controls.
  • Leadership in the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria.
  • Strong leadership and participation in design reviews by identifying risks associated with the product use and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process.
  • Influential partnership with R&D to drive safety and performance in new products
  • Previous experience in leading data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues.
  • Effective communication and previous experience in implementing compliance regulations and standards, including 21CFR820, ISO 13485, ISO 14971, ANSI/AAMI HE75 throughout the design and development process.

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 at

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

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