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Staff Design Quality Engineer (Software/Electrical)

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives.

We are currently seeking a Staff Design Quality Engineer (SW/EE) in Portage, MI to support design assurance activities for products in development.

Work Flexibility: Hybrid

This role requires reasonable proximity to our Stryker facility. You should be comfortable working 3 days a week onsite

What you will do:

• Support product quality sustainment through targeted exposure to post-market quality function and change controls process. Partner with R&D and execute quality improvement projects.

• Work closely with the R&D team to ensure that product designs meet quality requirements such as safety, and effectiveness; participate in collection of initial market feedback and customer preference testing.

• Work closely to Product Security and R&D teams to accomplish product security activities and ensure the design is in line with the cybersecurity required practices.

• Lead risk management activities for new product development teams by developing risk management plans and reports, conducting risk reviews, and verifying the implementation and effectiveness of risk controls.

• Partner with suppliers and manufacturing to implement robust process controls.

• Participate in design reviews and track how the design, documentation, and manufacturing process mitigate risks throughout the development process.

• Lead design validation activities including human factors engineering

• Support product design and quality transfers to internal and/or external manufacturing facilities.

• Analyze and define critical quality attributes for products and processes through risk analysis techniques.

• Contribute to the completion of final design verification and validation reports.

What you will need:

Required Qualifications:

• Bachelor’s Degree in Software Engineering, Electrical Engineering, or Computer Science Engineering (or other engineering degree with relevant electrical or software experience)

• 4+ years experience in quality, manufacturing, new product development, software or engineering.

Preferred Qualifications:

• Experience within medical device/manufacturing industry.

• Familiarity with ISO 13485 (medical device standard) and ISO 14971 (risk management standard).

• Data analysis (statistical analysis, sampling plans, statistical process control, Minitab) experience.

• 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.

• Six Sigma Certification.

• MS in engineering.

• 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.

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. Stryker 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 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required 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.