Staff Software Design Quality Engineer

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

Staff Software Design Quality Engineer

San Jose, CA; Orlando, FL; Portage, MI; or Fort Wayne, IN

Stryker is seeking a Staff Software Design Quality Engineer to support our Smart Care division's growing portfolio of digital, connected, cloud-based, and software-enabled healthcare solutions. This role sits at the intersection of software development, quality systems, risk management, and regulatory compliance, partnering closely with software engineering teams to ensure quality is integrated throughout the software development lifecycle. This is a strategic quality engineering role focused on process excellence, compliance oversight, and risk management rather than software testing or test execution.

Work Flexibility:

Hybrid work arrangement requiring on-site presence several days per week. Candidates must reside within commuting distance of San Jose, CA; Orlando, FL; Portage, MI; or Fort Wayne, IN.

What You Will Do

• Lead software quality and compliance activities for cloud-based, connected, Software as a Service (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 Failure Modes and Effects Analyses (FMEA), security risk reviews, and change-impact assessments throughout product development and sustaining activities.
• Review quality deliverables, design documentation, and release readiness packages to ensure compliance with applicable quality and regulatory requirements.
• Develop and improve quality procedures, work instructions, templates, and governance frameworks that support scalable software development practices.
• Support audit and inspection readiness activities, 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 drive quality-focused decision-making and process improvement initiatives.

Required Qualifications

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

Preferred Qualifications

• Master’s degree in Computer Engineering, Electrical Engineering, Software Engineering, Computer Science, or a related technical field.
• Experience supporting regulated software products, including Software as a Medical Device (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, Amazon Web Services (AWS), Microsoft Azure, Google Cloud Platform (GCP), iOS, or Android technologies.

United States of America Pay Ranges:

• USN: $102,600 - $171,000 USD Annual
• US5: $107,700 - $179,600 USD Annual
• US10: $112,900 - $188,100 USD Annual
• US15: $118,000 - $196,600 USD Annual
• US20: $123,100 - $205,200 USD Annual
• US30: $133,400 - $222,300 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.