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Staff Software Design Quality Engineer

Stryker
Portage, USA
Full-time
Senior · 4+ years experience
Onsite
USD 102600-196600 / year
Discovered 1 weeks ago
awsazuregcp

Full Job Posting

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.
  • What You Will Need

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.

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