Staff Software Design Quality Engineer

Stryker Corporation; Portage (MI); Hybrid; USD 120,000 - 210,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Stryker Corporation is seeking a Staff Software Design Quality Engineer to lead quality and regulatory activities for cloud-based, software-enabled medical solutions across multiple U.S. locations including Portage, MI.

The role emphasizes process excellence, risk management, and compliance within SDLC, not testing. Hybrid work arrangement with on-site presence several days per week; collaborate with software, cybersecurity, regulatory, privacy, IT, and operations teams to ensure quality is

Qualifications

• Bachelor's degree in Engineering, Sciences, or related technical discipline.
• Minimum 4 years of experience in a regulated industry (R&D, Quality, Software Eng, IT, Healthcare IT, or Systems Eng).
• Experience with software lifecycle methodologies (Agile, SAFe, or Waterfall).

Responsibilities

• Lead software quality and compliance activities for cloud-based SaaS medical software.
• Guide product teams through quality system processes and design control documentation.
• Conduct risk assessments and FMEA throughout development and sustaining activities.
• Review quality deliverables and release readiness for regulatory compliance.
• Develop quality procedures, templates, and governance for scalable software development.
• Support audit readiness and corrective actions.
• Integrate quality practices into Agile/DevOps/CI/CD environments.
• Partner with engineering, regulatory, privacy, IT, and operations teams to drive quality decisions.

Skills

Quality engineering

Software quality

Risk assessment

Agile/SAFe/Waterfall

Education

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

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: 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.

Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World's Best Workplaces!

For more information, visit: www.stryker.com

Work Flexibility

• Remote - Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location.
• Field-based - You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based.
• Onsite - Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category.
• Hybrid - You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.