Job Description

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.

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