Senior Quality Engineer, New Product Development (Hybrid)
Location: Redmond, Washington
Internal Number: R458762
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 stryker.com
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.
Stryker is hiring a Senior Quality Engineer, New Product Development(Hybrid) in Redmond, WA.
The candidate will need to live within a reasonable commuting distance to Redmond, WA facility. You will need to be in the office 2-3 days a week but will have the flexibility to work from home on the other days.
Who we want:
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
User-focused creators. People who imagine with the user in mind, developing technology that helps change patients' lives.
What you will do:
The Senior Quality Engineer, New Product Development provides experience and knowledge to the development of finished medical devices in the areas of design validation, risk management, and overall quality management system execution. The AQE is responsible to lead quality engineering activities that integrate the voice of the customer into the design and realization of new products.
Major Duties and Responsibilities:
Define User Needs by translating the voice of the customer feedback to design user needs.
Ensure that customer and regulatory requirements are incorporated into product specifications.
Lead Design Validation activities by:
Developing design validation plans
Being an advocate for human factors engineering practices, including identification of potential use errors and user interface-related risk control measures
Developing design validation reports that demonstrate requirements have been met before product is released to market.
Lead Risk Management activities by:
Developing Quality Reports that evaluate predicate product for relevant quality issues and assess critical risk to customers and patients
Developing Risk Management Plans
Developing Risk Tables through activities including risk analysis, risk evaluation, consideration of risk control, and evaluation of residual risk
Contributing to the development of Failure Modes and Effects Analyses
Developing Risk Management Reports, including evaluation of Overall Residual Risk and Benefit-Risk Analysis.
Utilize standard statistical methods and problem-solving techniques to ensure the development of robust test plans and design solutions.
Review and evaluate project documentation for compliance to Stryker quality procedures and other applicable regulations and standards as well as for sound technical competence to ensure we are delivering robust products.
Provide input throughout the product development process from a quality perspective.
Participate with marketing and design to understand user needs and translate those into engineering specifications that constitute the basis of the design.
Support new product development teams on the use of risk management tools, statistical methods, design and process control activities, and sound validation test planning to help drive quality up front in new product development.
Help guide new product development teams through our internal quality system to ensure products are developed in compliance to those procedures as well as the requirements of the FDA, ISO, and other regulatory bodies.
Initiate and build productive and collaborative internal/external professional relationships across multiple departments and teams such as R&D, Regulatory Affairs, Operations, and Marketing to ensure specific product development metrics are met. Encourage, inspire, and influence others, creating a positive impact on the team.
Ability to think critically, solve complex problems, and work on large cross-functional and diverse teams
What you will need:
Bachelor's degree in a science-related field, such as engineering, mathematics, etc., or relevant experience.
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