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 the #5 World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
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.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Motivated product launchers. Engineers who bring strategic direction and drive for execution to ensure products are developed and launched with precision.
As a Staff Advanced Quality Engineer 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.
What you will do
Execute quality assurance engineering work and provide input towards quality throughout the New Product Development for design quality and process quality.
Sound technical competence to ensure the delivery of robust designs, products, and processes.
Collaborate for process validation programs within New Product Development.
Lead process quality activities on newly created manufacturing lines.
Collaborate with design engineers to develop robust verification test strategies to ensure safe, reliable products are implemented.
Collaborate with manufacturing for process development and design for manufacturability.
You will support process validation for new product development to ensure long-term product quality.
Active participation of all activities during product launch, including driving non-conformances to resolution.
Lead risk analysis and develop mitigation strategies from a process perspective.
Execute to Stryker's Quality System for New Product Development and guide teams through the quality system to ensure products are developed in compliance to their procedures and the requirements of the FDA, ISO, and other regulatory bodies.
You will be required to build 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 may lead NC & CAPA, which require expertise in problem solving and root cause analysis.
Perform reliability engineering activities on prototypes with methods such as HALT and HASS to maximize product quality at launch
Create and update new/existing product development procedures for final quality inspection of a product.
What you will need
Bachelor of Science degree (B.S.) in Electrical Engineering, Biomedical Engineering, Mechanical or Engineering related discipline
5+ years of experience in an Engineering/Manufacturing environment or in a Quality Engineering role in a regulated environment
Experience with medical device development and manufacturing
Working knowledge of FDA, ISO, and other regulations and standards, e.g. ISO 13485, ISO 62366, and IEC 60601
Working knowledge of Risk Analysis, GD&T, SPC, Root Cause Analysis, Statistics and practical applications.
Process validation experience; preferred knowledge of GHTF approach to validation
ASQ Certifications (CQE, CRE, CQM, CSSBB)
Proficiency to understand and improve electrical designs and PCBA manufacturing processes
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