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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.
  • Travel Percentage: None
  • Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
  • Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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