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.
This Staff level Advanced Quality Engineer will join the Stryker Communications Infrastructure Quality Assurance team in the Dallas, TX area focused on new product development for our surgical light, surgical table, and boom portfolios (the immediate need is for them to support surgical lights). Our cross functional new product development teams operate globally across 3 sites in Flower Mound, Texas, Tuttlingen, Germany, and Gurgaon, India. We are passionate about driving innovation and working with our customers to improve healthcare through high quality product releases! This role will have the opportunity to engage with customers in the operating room setting in order to understand customer needs and challenges so that they can effectively drive patient safety and surgical workflow efficiency solutions to our customers through new product releases.
Who we want-
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.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
What you will do-
Partner with Engineering and Advanced Operations to define design requirements and develop manufacturing processes to support new product development projects. Lead risk management activities to ensure the highest level of product and process quality.
Develop quality assurance documentation to support new product development process and regulatory submissions.
Lead quality system maintenance by identifying and correcting deficiencies in procedures and practices.
Partner with cross-functional project teams to lead product and/or process design and development activities.
Lead risk management activities for new product development projects.
Evaluate overall residual risk for products prior to launch and present final risk/benefit justification to executive leadership.
Present risks associated with the product use during Design Reviews and track the design, documentation, and manufacturing process mitigate those issues throughout the development process.
Partner with cross-functional project teams to define design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.
Partner with Advanced Operations in the development of manufacturing processes for new products.
Utilize standard statistical analysis and problem-solving techniques to determine product acceptance limits, establish process parameters, resolve quality problems, etc.
Develop, review, and approve inspection plans, routers, and product drawings for new products.
Support product design transfers to internal and/or external manufacturing facilities.
Provide support and direction for other Quality Engineers.
Evaluate predicate products for relevant quality issues tthat may impact new product development projects.
Analyze and define critical quality attributes for product and process through risk analysis techniques.
Participate in collection of initial market feedback on new products and address early concerns.
Contribute to the completion of final design verification and validation reports by providing concise conclusions with statistical validity and graphical support.
What you need-
BS in a science, engineering or related discipline.
Minimum of 4+ years experience preferred.
Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.
Demonstrated ability to read and interpret CAD drawings.
Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.
Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).
Must possess strong project management skills as well as have the ability to manage multiple tasks simultaneously.
Demonstrated ability to advocate for product excellence and quality.
Demonstrated ability to effectively work cross-functionally with other departments, including Advanced Operations, Product Development, Regulatory Affairs, and Marketing.
Strong interpersonal skills, written, oral communication and negotiations skills.
Strong in critical thinking and "outside the box" thinking.
Highly developed problem solving skills. Strong analytical skills.
Demonstrated ability to successfully manage and complete projects in a matrix organization.
Demonstrated ability to work independently.
Experience in working in a compliance risk situation.
Computer literacy (including proficiency with Mini-Tab or similar analysis program).
Some travel may be required.
MS, CQE, or CRE preferred.
Six Sigma Green or Black belt preferred.
Prefer experience with medical device product development lifecycle, including risk management and design/process verification and validation.
Thorough knowledge and understanding of US and International Medical Device Regulations
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