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.
Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
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:
The product safety engineer ensures each surgical robotic project meets EMC/EMI and safety regulations and expectations. Provide technical direction to product development groups, evaluate new products and current product changes to the applicable regulations and standards as applicable within the medical environment. Coordinate with CSA, UL, TUV, and other regulatory agencies. Coordinate with external test facilities. Provide technical guidance to support existing efforts and external objectives for multiple country support.
The engineer will support product safety efforts for existing field products, support the continuous improvement, and new product design of Stryker products. Design, develop, and negotiate product safety elements for medical robotic and surgical applications. The engineer will be integral to problem solving assigned field issues with electrical and product safety scope. The engineer will generate detailed solutions and release applicable documentation. The engineer will lead and mentor other engineers. Works closely with manufacturing, quality assurance, other engineering teams, and program management to deliver products. Execute project plans. Review peer designs. Contribute to building and testing of prototypes.
Collaborates with internal manufacturing partners, contract manufacturers, designers and product specialists to optimize designs for manufacturability. Utilizes CAD (Computer Aided Design) or CAE (Computer Aided Engineering) systems to model new designs and produce detailed engineering drawings.
This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. This position requires professional mastery of a specialized field of expertise that typically requires a college degree or equivalent. The job requires professional knowledge gained through substantial applicable work experience, to supplement formal knowledge, in order to apply principles and concepts of own subject/technical discipline in resolving issues as they arrive.
Work with new and sustaining development engineering and operations teams to ensure product compliance to global safety standards.
Support development engineering with the technical understanding of the required safety standards.
Carry out design analysis to support the product development within safety standards scope.
Ensure product safety elements are design into the product early in the development cycle by identification, analysis, and/or implementation.
Understand and interpret IEC60601-1 and related standards.
Coordinate safety testing, including EMI/EMC, wireless, basic safety and evaluate test results.
Conduct root cause analysis and implement due diligence actions to resolve product safety issues.
Drive safety design reviews with the development engineering.
Provide support to external test houses during product testing.
Interact with outside safety agencies and support audits, as needed.
Collaborate with other departments, divisions, R&D, other product development resources, and contractors.
Support Stryker's international products launches for global markets, as needed.
Serve as interface between development teams and CSA, UL, ETL, TUV and other regulatory agencies.
Maintain proficiency of worldwide safety regulations through research, development of the network, and ongoing education.
Train in and obtain certification to perform testing to IEC 60601 series standards, and other standards, as needed.
Create and maintain appropriate reports and related documents.
Advance use development tools, such as oscilloscopes, multi-meters, and soldering stations.
Investigates electrical based field problems to root cause and propose resolutions and implement corrective action.
Document and release the corrective action.
Develop and apply advanced circuit and electrical system prototype and test methods.
Conduct and design research and studies to support product design.
Advanced use of manufacturing principles
Advanced use of quality assurance documentation in the medical industry.
Generate and communicate schedules to a broad technical audience.
Clearly communicate status of team assignments and coordinate team tasks.
Ability to lead small team of engineers and shift priorities as dictated by project demands.
Basic soldering and reworking electronics.
Promote industry best practices. Apply Stryker and industry best practices.
What you need:
Bachelors, Masters, or Doctorate (PhD) Electrical / Electronics Engineering degree from an ABET accredited school
10+ years' experience
Expert experience with IEC60601-1 and related standards.
Experience working with design of electronics (printed circuit boards, cables) with emphasis on manufacturability.
Experience working in medical device quality system or other regulated industry
Advanced knowledge of electrical engineering principles.
Be detailed oriented with strong written, verbal, interpersonal and organizational skills.
Knowledge of design tools (Altium or Orcad/Allegro design tools) a plus.
Knowledge of analysis tools and statistical methods a plus.
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