Staff Design Quality Engineer (Software/Electrical)
Summary
On-site Staff Design Quality Engineer (Software/Electrical) at Stryker partnering with R&D to ensure medical-device product designs meet safety and effectiveness requirements. Leads risk management, design validation, and product-security activities across the development lifecycle.
Stryker is hiring a Staff Design Quality Engineer (Software/Electrical) in Portage, Michigan to support our Medical business. In this role, you will provide on-site quality support for new product development and partner with cross-functional teams, including R&D, Operations, Product Security, Testing, and Regulatory, throughout the development process. You will develop electrical and software development plans, support execution of those plans, and provide post-market quality support through the change control process. You may also support quality improvement projects.
What you will do:
- Partner closely with R&D to ensure product designs meet quality requirements for safety and effectiveness. Support the collection of market feedback to inform design requirements and validate the design with customers as it matures through the production launch.
- Work closely with 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 Operations and suppliers to ensure supplier processes and Stryker manufacturing processes 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 usability 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.
- Support PPAP planning, communicate PPAP requirements to component suppliers, and support PPAP approval.
What you will need
- 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
- Experience within medical device/manufacturing industry.
- Familiarity with ISO 13485 (medical device standard) and ISO 14971 (risk management standard), IEC-62304 (software development life cycle)
- 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.
- ASQ CSQE certification.
United States of America Pay Ranges:
- USN: $89,300 - $148,800 USD Annual
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