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.
Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
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.
What you will do
As a Staff Engineer - Design Assurance, you will be responsible for leading quality engineering efforts for new product development. You will have the responsibility to drive reliability engineering, human factors engineering, risk management, and design validation, while ensuring compliance to FDA Quality System Regulations and ISO 13485.
You will guide new product development teams through internal quality system requirements to launch new products.
You will lead risk management for projects, including risk analysis and development of sound mitigation strategies.
You will use quality engineering tools, statistical methods, design development methods, process development and control methods, and design verification and validation planning to build quality into new products during development.
You will lead HFE activities to develop intuitive and safe new products.
You will lead design validation efforts to ensure new products meet all customer user needs.
You will support process validation for new product development to ensure long-term product quality.
You will develop and create procedures for incoming, in-process and final inspection of components and finished goods.
You will be the voice of Quality in a cross-functional team .
You will foster strong relationships through open communication, respect and trust.
You will evaluate project tangibles for technical competence and compliance to ensure we are delivering robust products.
You will support complaint investigation and post market activities.
You may lead NC & CAPA, which require expertise in problem solving and root cause analysis.
What you need
Bachelor's Degree in Mechanical Engineering, Biomedical Engineering or equivalent discipline is required.
A minimum of 4+ years of experience in a Technical Engineering or Quality Engineering position within an R&D or manufacturing environment
A minimum of 3 years of experience as an AQE or Design Quality Engineer is highly preferred
Previous experience in a regulated environment preferred
ASQ CQE, CRE, CSSBB or equivalent course work / experience desirable
Proficient understanding of Med Device manufacturing processes highly preferred
Familiarity with ISO 13485, GDP, GMP preferred
Internal Number: R449887
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