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 stryker.com
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 Staff Design Assurance Engineer you will lead Sustaining Quality Engineering activities in the development and maintenance of orthopedic products to ensure the highest level of product and process quality. You will also provide guidance to the Sustaining Product Development teams to ensure compliance to the company's quality system and external standards.
Knowledge of FDA QSRs, ISO 13485 Design Control Procedures and ISO 14971
Knowledge of Medical Device Regulation preferred
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 read and interpret CAD drawings
Demonstrated ability to advocate product excellence and quality
Demonstrated ability to effectively work cross functionally with other departments including Operations, Product Development, Regulatory and Marketing.
Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines.
Demonstrated ability to work well in the gray, navigating creative solutions through cross functional collaboration
NC/CAPA experience preferred
Computer proficiency with Mini-tab or similar analysis program
What you need
Bachelor's Degree in Engineering; Biomedical, Mechanical or related discipline
Minimum 4 years of experience as a Quality Engineer (QE) or Engineer in a regulated design environment.
Highly prefer experience within medical device product development life cycle, including risk management, usability engineering and design/ process verification & validation
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