Staff Software Design Quality Engineer

Stryker • Portage, MI

1d • Hybrid

About The Position

Stryker is seeking a Staff Software Design Quality Engineer to support the Smart Care division’s growing portfolio of digital, connected, cloud-based, and software-enabled healthcare solutions. The role operates at the intersection of software development, quality systems, risk management, and regulatory compliance, partnering with software engineering teams to integrate quality throughout the software development lifecycle. It focuses on process excellence, compliance oversight, and risk management rather than software testing or test execution.

The position has a hybrid work arrangement requiring on-site presence several days per week. Candidates must live within commuting distance of San Jose, California; Orlando, Florida; Portage, Michigan; or Fort Wayne, Indiana. Travel is not required.

Requirements

• Bachelor’s degree in Engineering, Sciences, or a related technical discipline.
• At least 4 years of experience in a regulated industry within Research & Development, Quality, Software Engineering, Information Technology, Healthcare IT, or Systems Engineering.
• Experience with software development lifecycle methodologies, including Agile, SAFe, and/or Waterfall.
• Experience with software risk management, software FMEA, security risk assessments, defect management, software verification, and software validation activities.

Nice To Haves

• Master’s degree in Computer Engineering, Electrical Engineering, Software Engineering, Computer Science, or a related technical field.
• Experience supporting regulated software products, including SaMD, software-enabled medical systems, digital health, or telehealth solutions.
• Experience with medical device quality and regulatory standards, including FDA regulations, IEC 62304, IEC 82304, or related frameworks.
• Experience supporting cloud, mobile, artificial intelligence/machine learning, AWS, Microsoft Azure, GCP, iOS, or Android technologies.

Responsibilities

• Lead software quality and compliance activities for cloud-based, connected, SaaS, and software-enabled medical technologies.
• Guide product development teams through software development lifecycle requirements, quality system processes, and design control documentation.
• Conduct risk assessments, software FMEAs, security risk reviews, and change-impact assessments throughout product development and sustaining activities.
• Review quality deliverables, design documentation, and release readiness packages for compliance with applicable quality and regulatory requirements.
• Develop and improve quality procedures, work instructions, templates, and governance frameworks for scalable software development practices.
• Support audit and inspection readiness, including evidence collection, gap assessments, corrective actions, and compliance monitoring.
• Integrate quality and risk management practices into Agile, DevOps, and continuous integration/continuous deployment environments.
• Partner with engineering, cybersecurity, regulatory, privacy, information technology, and operations teams to support quality-focused decisions and process improvements.

What This Job Offers

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