Staff Software Design Quality Engineer

Regulatory Jobs; Portage (MI); Hybrid; USD 118,000 - 197,000; Full time

Job summary

Stryker is seeking a Staff Software Design Quality Engineer for its Smart Care division, spanning digital, cloud-based, and software-enabled medical solutions. The role blends software development with regulatory compliance and risk management.

The position is hybrid or onsite with multiple US locations. You will drive quality systems, guide lifecycle processes, conduct FMEA and security reviews, and help teams deliver compliant software products at scale.

Qualifications

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

Responsibilities

• Lead software quality and compliance activities for cloud-based SaaS and software-enabled medical technologies.
• Guide product development teams through 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 for regulatory compliance.
• Develop and improve quality procedures, templates, and governance for scalable software development.

Skills

Quality engineering

Regulated industry

Software lifecycle

FMEA

Risk assessment

Agile

Regulatory compliance

Education

Bachelor’s degree in Engineering or related field

Master’s degree in Computer/Software/Electrical Engineering or CS

Job description

Work Flexibility: Hybrid or Onsite

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.

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: NoneStryker 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.