(Senior) Project Engineer (m/f/d) with focus on Biocompatibility and Project Management
Internal Number: R458254
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.
As a (Senior) Project Engineer (m/f/d) with focus on Biocompatibility you will be a Subject Matter Expert advising and determining biological safety for Trauma & Extremities products. You will collaborate with Manufacturing, Quality, Research & Development, Regulatory Affairs as well as external regulatory bodies to drive state of the art in Trauma & Extremities divisions products and processes.
Your key responsibilities
In your new role you lead biocompatibility project activity, communicate timelines, deliverables and study outcomes to leadership as well as serve as the primary liaison to the project development team.
You will provide guidance to associated team partners within Manufacturing, Quality, R&D and Regulatory Affairs on the impact factors of biocompatibility.
You develop and collaborate on business strategies to ensure compliant and efficient biocompatibility evaluations.
You guide development and documentation of test plan protocols, reports, standard operating procedures and specifications.
You develop and deliver responses to biocompatibility related questions supporting regulatory submissions.
Furthermore, you influence organization excellence by recommending approaches, procedures and work aids as they relate to biocompatibility, in compliance with applicable global regulatory requirements.
What are we looking for?
You have successfully completed a Bachelor or Master of Science in Mechanical Engineering, Biomedical Engineering, Chemistry, Biology or any related scientific degree.
You have a fundamental understanding or direct experience with the ISO 10993 standards, medical device manufacturing processes and biocompatibility assessment methodology.
You have 2+ years technical leadership experience in a cross-functional organizational setting as team lead or project management role.
You have the ability to engage and influence others to accomplish project deliverables.
Your profile is completed by excellent communication skills: Fluency in English is mandatory. Dual-fluency in German is preferred.
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