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, information, use cases, and industry analyses to develop best practices.
Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
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.
What you will do-
The Staff NPI Quality Engineer will reside within the GQO Quality Assurance organization and work collaboratively with Advanced Operations and Design Assurance, with responsibility for quality assurance activities, including, but not limited to the following:
Foster collaborative internal/external professional relationships across Design Divisions, Advanced Operations & GQO functions associated with design transfer activities.
Communicate effectively with all internal customers, stakeholders, and project teams to deliver successful project transfers with the highest levels of quality that meet the NPI project goals.
Mentor other groups and functions on areas of expertise with particular attention to design and process transfer.
Proficient in risk management practices and tools, having high expertise in failure modes associated with production and production related processes, (PFMEA).
Ensure all Risk Management outputs comply with ISO14971.
Support Design team to complete CQA/CTQ identification and inputs to dFMEA.
Develop and implement lean inspection strategies and inspection plans through state-of-the-art inspection methods and technologies. Ensure inspections are repeatable, efficient, and scalable.
Lead continuous improvements of inspection methods and sampling plans, with a focus on human error risk elimination.
Support the development, execution, and approval of validation strategies, with the goal of highly capable processes, that result in high yield and enable scalability. Approve protocols and reports, including data analysis.
Influence processes towards validation versus manual verification, where possible.
Support Sterilization validation activity, as required.
Represent quality assurance during the DTAP (Design Transfer Agreement Plan) process, ensuring product launches meet or exceed established metric targets including Right First Time (RFT), manufacturing loss, inspection costs per unit and product escapes, in conjunction with other targets per the DTAP.
Provide subject matter expertise in Design transfer processes and procedures, participating and interfacing in internal & external audits with regulatory representatives.
Represent NPI Quality Assurance at Design reviews and ensure integrity of the process design through robust NPI quality deliverables.
What you need
Bachelor of Science, Engineering or related subject with 4+ years' experience in a quality or technical discipline
Previous experience in a regulated environment within a manufacturing environment required. 2 years' experience in new product/process is a distinct advantage.
Masters of Science, Engineering or related subject with 3 years of experience in a quality or technical discipline
CQE or equivalent course work / experience desirable
Familiarity with advanced product quality planning framework and techniques used to develop products, a distinct advantage.
Proficient in understanding of Med Device manufacturing processes desirable.
Familiarity with ISO 13485, QSR, GDP, GMP desirable.
Lean Six Sigma training a distinct advantage.
Highly proficient in all aspects of Validation. Computer System validation a distinct advantage.
Analytical & problem solving skills, process improvement orientation, and the ability to handle multiple tasks.
Competency in Metrology including ability to interpret complex engineering drawings and understand geometrical dimensioning and tolerance.
Must be able to generate, follow and explain detailed operating procedures
Experience in executing complex problem-solving and process improvements techniques related to design/process/technical issues using lean six sigma tools.
Ability to manage several projects at once.
Excellent interpersonal skills - able to express ideas and collaborate effectively with multidisciplinary teams.
Working knowledge/experience of risk based and statistical techniques, in particular process risk, failure mode and effect analysis (FMEA), statistical sampling plans, process capability and MSA's.
Manages change well and adopts a continuous improvement mindset
Ability to be the voice of quality when dealing cross functionally
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