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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
Job title Engineer, Design Assurance PSS
Reports to: Manager, Design Assurance PSS
Main purpose of role
Lead design control and risk management processes throughout the patient specific design process. Work cross functionally to drive our company's mission and strengthen the Stryker Brand. Provide guidance to the design teams to ensure product compliance to the company's quality system and external standards.
Develop quality assurance documentation to support the new product development process and regulatory submissions.
Support quality system maintenance for the design control process by identifying and correcting deficiencies in procedures and practices.
Manage, lead, or assist in resolving nonconformities and CAPA.
Engage in the design, development, manufacturing, and risk management activities for new product development projects.
Lead risk management activities by developing risk management plans and reports, conducting risk reviews, verifying implementation and effectiveness of risk controls.
Participate in design reviews by identifying risks associated with the product use and tracking how the design, documentation, and manufacturing process mitigate those issues.
Support the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria.
Contribute to the completion of final design verification and validation reports by providing concise conclusions with statistical validity and graphical support.
Utilise data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues.
Qualifications, skills and desirable experience
Minimum of 0+ years' experience ideally in a strongly regulated environment such as medical device, military or aerospace industry
Bachelor's Degree in science, engineering or a related discipline
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 is preferred.
Experience in the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria is preferred.
Demonstrated ability to effectively work cross-functionally with other departments to drive safety and performance
Previous experience in 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 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