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
Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices
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 Engineer - Design Assurance you will lead quality engineering activities in the development of orthopedic products within the Robotics Design Assurance team ensuring the highest level of product and process quality. Provide guidance to the New Product Development teams to ensure compliance to the company's quality system and external standards.
Participate in design, development, manufacturing and risk management activities of tied to high-volume product launches
Participate in the evaluation of overall residual risk for products prior to launch and present final risk-benefit justification to executive leadership
Participate in design reviews by identifying risks associated with the product use and tracking how the design, documentation and manufacturing process mitigate of those issues throughout the development process
Support Product Development in the definition of design verification and validation test requirements that will ensure appropriate objective evidence is available to support the acceptance criteria
Support Advanced Operations in the development of manufacturing processes for new products
Support product design transfers to internal and/or external manufacturing facilities
Develop quality assurance documentation to support regulatory submissions
Work with complaint investigators to complete post-market health risk assessments
Support quality system maintenance primarily for the design control process by identifying and correcting deficiencies in our procedures and practices
Manage, lead and/or assist in resolving nonconformities and corrective/preventive actions (CAPA)
Support design, development and manufacturing of robotic systems, software and instruments.
Lead risk management activities for robotics by developing risk management plans/reports, conducting risk reviews, verifying implementation and effectiveness of risk controls and driving post market activities.
Partner with engineering to define design verification and validation test requirements that will ensure appropriate objective evidence is available to support the acceptance criteria. Promote efficient testing practices.
Complete or contribute to the completion of final design verification and design validation test reports by providing clear concise conclusions with statistical validity and graphical support when necessary.
Utilize standard statistical analysis and problem solving techniques as necessary to determine product acceptance limits, establish process parameters, resolve quality problems, etc.
Identify supplier assessment requirements and communicate these to the supplier quality group.
Evaluate product design changes for verification and validation requirements and assist in change implementation.
What you will need
Bachelor's in science in engineering or related discipline
Minimum 2+ years of experience as a Quality Engineer (QE) in a regulated design environment. Prefer experience with medical device product development life cycle, including risk management and 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 read and interpret CAD drawings preferred
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