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.
Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.
Data managers. People who enjoy compiling, organizing and consolidating large volumes of data and reports.
Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management and leadership teams.
Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities
What you will do:
Collaborate with cross-functional teams to develop the best in-class user needs that drive objective validation studies.
Create and maintain various Design Control deliverables pertaining to the testing of the system including validation test plans; human factor validation protocols and summary test reports.
Engage with Key Opinion Leaders to better understand the needs of all stakeholders interacting with the system and the operational environment of end users and patients. Observe clinical procedures, demonstrate prototypes and validate design with end-users.
Apply in-depth knowledge of the operating room environment and medical technology to perform clinically relevant design validation testing to demonstrate that the device can be used safely and effectively in real-world use scenarios.
Lead various design validation activities such as scheduling and preparing stimulated use environments, managing participant recruitment, defining risk-driven acceptance criteria for the tests, and coordinating all data collection efforts and analyses of results.
Participate in various user-centric development activities to confirm user needs are met effectively in all aspects of device design, packaging, labeling and training.
Build partnerships with various Robotics R&D partners such as Medical Education, Upstream and Downstream Marketing to strategize and mimic field-training in support of successful medical device launch.
Proactively drive improvements into the Design Validation process that improves quality and reduces project and product risk.
Keep abreast of industry best practices and recalls or challenges in relation to Design Validation to ensure our practices stay current and establish strategy for keeping the team up to date on latest advances in Design Validation.
Mentor and train others on established Design Validation process and best practices.
What you need::
Bachelor's degree or foreign education equivalent in Biomedical Engineering, Electronic Engineering, Human Factors Engineering or other relevant degree and 8 or more years of industry experience validating complex hardware/ software or systems. OR, in the alternative, Master's degree or foreign education equivalent in Biomedical Engineering, Human Factors Engineering, Electronic Engineering, or Electrical Engineering and 6 or more years of industry experience validating complex hardware/software or systems.
Interpreting FDA Guidance documents and standards such as IEC 62366, 60601-1-6, HE75 and applying them to medical device product development.
Authoring clinical testing protocols, execute studies and analyze feedback to drive development of product and clinical experience that meets user needs.
Utilizing software tools for statistical analysis of data including Minitab, defect and test management.
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