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.
Primarily responsible as Product Development point of contact for the oversight of the NC/CAPA process and procedures relating to patient specific solutions. Ensure that NCs and CAPAs are compliant, effective, and efficient in dealing with quality issues. Facilitates proactive and effective resolution of issues through expertise in problem-solving methodology and process improvement.
Work as Product Development point of contact for Patient specific products team and ensure compliance to NC/CAPA processes and procedures
Contribute in scoping, analyzing gap in design by challenging to improve in areas manufacturing, inspection, GD&T, V&V, design documents
Responsible for review and approval of NCs and CAPAs, with attention to detail, review for completeness, accuracy, effectivity, and timeliness along with the review and approval of CAPA changes and extension requests
Develop and deliver training and coaching for new NC/CAPA users on principles and system requirements
Liaise with relevant functional groups, facilitate and mentor patient specific solutions team members through all stages of the NC/CAPA process
Contribute in development of optimum future state of the NC/CAPA process for business needs in alignment with Corporate direction with regard to patient specific solutions processes
Ensure users provide necessary rigor to the electronic NC/CAPA system content including maintenance of a live record with all relevant evidence attached in a timely manner
Facilitate and coach NC and CAPA teams in the application of problem-solving techniques and promote its uses and development (e.g. human error reduction, 4-D, five whys, etc.).
Act as a subject matter expert on all patient specific solutions related procedures, ensuring compliance to the relevant procedures and serve as electronic NC/CAPA super-user
Lead and execute patient specific solutions NC/CAPA review forums
Liaise with other sites and departments to ensure compliance to global requirements and metrics are achieved
Provide input and review of patient specific solutions related procedures
Identify and lead continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports for the improvement and optimization of patient specific solutions related processes
Lead and participate in cross-site and corporate project teams in areas of CAPA and quality system improvement
Lead and coordinate preparation, participation and follow-up for Stryker internal, Corporate, and third party audit activities with regard to patient specific solutions related NCs/CAPAs
Hands on with UG NX (Preferred), Creo/ Pro E.
Qualifications, skills and desirable experience
BE/B.Tech/ME/M. Tech in Mechanical Engineering /Bio Medical Engineering
3- 6 years of relevant work experience, at least 2 years in area of in area of quality systems, engineering, or equivalent experience preferred
Skilled in interpreting design, analyzing and doing DFM, DFI, materials and manufacturing
Basic level of GD&T and tolerance analysis good to have
Experience in interacting with cross functional teams including medical device regulatory
Thorough knowledge of U.S., European, and international regulatory industry guidelines/standards and ability to interpret and apply
Effective communication and knowledge of compliance regulations and standards, including 21CFR820, ISO 13485, ISO 14971 throughout the design and development process
Strong knowledge of supporting Quality Systems (audits, management review, quality planning, etc.)
Must possess strong communication, project management and influencing skills and have the ability to manage multiple tasks simultaneously
Strong interpersonal skills, with demonstrated ability to manage and interact with multiple stakeholders at different levels and areas of the organization
Highly developed problem-solving skills with demonstrated successful resolution of project-level issues
Demonstrated ability to successfully manage and complete projects in a matrix organization
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