Staff Software Quality Engineer

Stryker • Portage, MI

10d • Hybrid

About The Position

Our Instruments group is the leader in creating products that make surgery more efficient, reduce trauma, and improve techniques. We are known for a wide range of innovative operating room products, from leading surgical power tools to personal protection and waste/ fluid management. Our goal is to improve the surgical and patient experience by developing products that are more reliable and less complicated to use. Know more about the similar products you will work on: Sonopet IQ Core 2

Requirements

• Bachelor's or master’s degree in software engineering, Computer Science, Computer Engineering, Electrical Engineering, or related field, or equivalent discipline is required.
• 4+ years of relevant experience
• Regulated industry experience, such as Medical, Aerospace, Defense, Communication, and/or automotive embedded software control(Medical device experience is preferred).

Nice To Haves

• 2-3 years’ experience in an equivalent position within an R&D environment is preferred
• 3+ years of experience in software testing or quality is a distinct advantage

Responsibilities

• Lead software defect management activities across all phases of the software development lifecycle, including tracking, root cause analysis, and resolution.
• Provide quality and engineering input throughout the SDLC, with primary focus on requirements definition, test planning/execution, security, risk management, and regulatory compliance.
• Manage and oversee software builds, change control, and configuration management using tools such as Perforce, ensuring traceability and compliance.
• Partner with cross-functional engineering teams (software, electrical, mechanical, and industrial design) to ensure embedded software meets product and system design requirements.
• Perform requirements analysis, design, and software reviews (including SOUP software), and system risk assessments aligned with design controls.
• Guide New Product Development (NPD) teams through quality system requirements, ensuring compliance with internal procedures, FDA, ISO, and other regulatory standards.
• Develop, execute, and document verification and validation activities, including test strategies, test cases, and quality metrics.
• Support software reliability and risk management activities, ensuring readiness for release and sustained product quality.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level