New · posted Oct 14
Stryker · Medical Devices
Staff Software Design Quality Engineer
- Portage, MI
- Hybrid
- Full-time
- Senior & Principal
Open until filled
The role
Work Flexibility: Hybrid or Onsite
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 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 Qualificationsnice to have
- 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.
What you'll 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.
Pay
$102,600 – $222,300 a year
Employer providedUnited 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
Where you'll work
Portage, MIHybridOpen in Maps (opens in a new tab)
More jobs in Portage, MIEqual opportunity, accessibility and legal noticesStryker's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 14, 2026
Salary intelligence
How the pay compares
This role's midpoint is 30% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in Michigan11 roles publishing pay
Senior & Principal roles in the US221 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $102,600 | — | $222,300 |
| Michigan (middle half) | $104,000 | $119,000 | $119,000 |
| All US (middle half) | $105,500 | $124,500 | $142,000 |
This role: Stryker's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 14, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 598 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Stryker's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 19 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Data and digital systems10
- GMP and compliance6
- Quality systems and risk6
- Collaboration and leadership4
- Documentation and SOPs3
- Lab testing and methods2
- Validation and qualification1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
- IECIEC 62304(official source, opens in a new tab)Software life cycle processes for medical device software
Company hiring pulse
Stryker on Regulatory Jobs
- 54
- Open roles
- 46
- Distinct roles
- 17
- Locations
By discipline
- Quality43 80%
- Regulatory9 17%
- Compliance & Safety2 4%
By level
- Senior & Principal30 56%
- Associate & Specialist18 33%
- Manager6 11%
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Staff Software Design Quality Engineer at Stryker
Open until filled. $103K–$222K a year, employer provided.