Staff Quality Engineer, Design Assurance NPD - Human Factors
Location: Mahwah, New Jersey
Internal Number: R456083
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 the #5 World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
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.
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.
Stryker is one of the world's leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world.
Together with our customers, we are driven to make healthcare better.
At Stryker, quality is first in everything we do. We are driven to make healthcare better for our customers by
providing innovative products and services that meet regulatory requirements through our effective quality system.
The Company was founded in 1941 by Dr. Homer Stryker and incorporated in 1946 as the Orthopedic Frame Company. In 1964, the Company’s name was changed to Stryker Corporation.
• $13.6 billion in annual sales in 2018; annual revenue has grown for 39 straight years
• 17.1% CAGR (compound annual growth rate) in sales over 39 years
• ~36,000 employees globally in 2018
• 43 manufacturing and research & development locat...ions worldwide
• Included in the Standard & Poor’s 500 Index
• Ranked # 233 on Fortune Magazine’s “FORTUNE 500” list for 2019
• Ranked # 3 on Fortune Magazine’s “World’s Most Admired Companies” list for the “Medical Equipment” industry for 2019
• Ranked # 11 on Fortune Magazine’s “100 Best Companies to Work For” list (U.S.) for 2019
• Spent $862 million on R&D in 2018
• 7,784 patents owned globally in 2018
• Initial public offering of stock was in 1979
• Listed on the New York Stock Exchange under ticker SYK