Senior Design Quality Engineer (Hybrid)

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.

Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team: https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-team

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
• 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.

• Work closely with the R&D team to ensure that product designs meet quality requirements such as safety, effectiveness; participate in customer preference testing and apply learnings towards usability.
• Lead risk management activities for new product development teams by developing risk management plans and reports, conducting risk reviews, verifying implementation and effectiveness of risk controls.
• Partner with suppliers and manufacturing to implement robust process controls.
• Participate in design reviews and lead risk management associated activities - tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process.
• Lead design validation activities including human factors engineering
• Monitor compliance to Stryker's Quality Procedures and FDA Quality System Regulations (QSR's) as well as all other product specific standards/regulations and guide the team as necessary.
• Support product design and quality transfers to internal and/or external manufacturing facilities.

• Bachelor's Degree in Mechanical Engineering (or other engineering degree with relevant mechanical experience).
• 2+ years experience in new product development, quality, manufacturing, or mechanical engineering.

• Ability to think critically, solve complex problems, and work with and influence large cross-functional and diverse teams.
• Experience within medical device/manufacturing industry preferred.
• Familiarity with ISO 13485 (medical device standard) and ISO 14971 (risk management standard) preferred.
• Data analysis (statistical analysis, sampling plans, statistical process control, Minitab) experience is preferred.
• Six Sigma Green or Black belt preferred.
• MS in engineering preferred.
• Demonstrated ability to successfully manage and complete projects in a matrix organization, as well as work cross-functionally with other departments including Advanced Operations, Research and Development, Regulatory Affairs, Clinical Sciences and Marketing.

• 12 paid holidays annually
• Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
• Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.