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Stryker Advanced Quality Engineer (New Product Development) in Portage, Michigan

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

We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

Stryker is hiring an Advanced Quality Engineer (Hybrid) in Portage, MI to support our Medical Division ! In this role, you will have the unique opportunity to support the development of one or more products from concept generation through production, experiencing the entire product lifecycle.

You will provide input to R&D designs from a quality perspective, work with a cross functional team to develop test strategies for product designs, and analyze the risk associated with these designs to recommend improvements to new and existing product design.

Work Flexibility: Hybrid. This role requires reasonable proximity to our Portage, MI. You should be comfortable working 3-days onsite.

Who we want:

  • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

  • Collaborative partners . People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

  • Curious learners. Engineers who seek out cutting-edge research and information to expand and enhance their ability to design medical devices.

What you will do:

  • 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 (usability).

  • 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.

What you need:

Required Qualifications:

  • Bachelor's degree in engineering is required. Preferred to be mechanical or biomedical.

  • 0+ required years of experience.

Preferred Qualifications:

  • 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.

About Stryker

Our benefits:

  • 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.

For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits (https://cdn-static.findly.com/wp-content/uploads/sites/1427/2023/09/20143933/us-stryker-employee-benefits.pdf)

About Stryker

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com. (http:)

Know someone at Stryker?

Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program on our referral page (https://careers.stryker.com/referrals/)

Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

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