Hybrid Staff Software Design Quality Engineer SaMD & Cloud

Stryker; Portage (MI); Hybrid; USD 103,000 - 222,000; Full time

Job summary

Stryker is seeking a Staff Software Design Quality Engineer to support its Smart Care portfolio of digital and software-enabled medical solutions. The role blends software development, quality systems, risk management, and regulatory compliance, with a focus on process excellence and governance rather than pure testing.

Hybrid work is required; candidates must reside within commuting distance of the listed locations.

Qualifications

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

Responsibilities

• Lead software quality and compliance activities for cloud-based SaaS and software-enabled medical technologies.
• Guide product development teams through software lifecycle requirements, quality system processes, and design control documentation.
• Conduct risk assessments, FMEA, security risk reviews, and change-impact assessments throughout development and sustaining activities.
• Review quality deliverables, design docs, and release readiness packages to ensure regulatory compliance.
• Develop and improve quality procedures, work instructions, templates, and governance for scalable software development.
• Support audit and inspection readiness activities, including evidence collection, gap assessments, and corrective actions.
• Integrate quality and risk management into Agile, DevOps, and CI/CD environments.
• Partner with engineering, cybersecurity, regulatory, privacy, IT, and operations teams to drive quality-focused decisions.

Skills

Agile

SAFe

Waterfall

Software risk management

FMEA

Education

Bachelor’s degree in Engineering, Sciences, or related technical discipline

Tools

AWS

Azure

GCP

iOS

Android

Job description

Stryker is seeking a Staff Software Design Quality Engineer to support its Smart Care portfolio of digital and software-enabled medical solutions. The role blends software development, quality systems, risk management, and regulatory compliance, with a focus on process excellence and governance rather than pure testing.

Hybrid work is required; candidates must reside within commuting distance of the listed locations.