Staff Design Quality Engineer (Software/Electrical)

Stryker is hiring a Staff Design Quality Engineer (Software/Electrical) in Portage, Michigan to support our Medical business.

About the role

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.

Responsibilities

• 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.

Requirements

• 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.

Qualifications

• 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.

Pay

United States Pay Range: $89,300 - $148,800 USD Annual. View the U.S. work location and transparency guide to find the pay range for your location.

Benefits

• Health benefits: 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: 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.

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.