Senior Software Quality Engineer, Design Assurance at Stryker

Portage, Michigan, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Digital HealthIndustries

Requirements

Bachelor’s degree in a science or engineering field
Minimum of 2+ years of experience working in a highly regulated industry following cGMP and GDP regulations in Research & Development (R&D), Quality (QA/QC), Software Engineering, Information Technology, Healthcare IT, or Systems Engineering
Ability to commute to one of the following locations: San Jose, CA; Orlando, FL; Portage, MI; or Fort Wayne, IN (hybrid role with in-office presence Monday through Wednesday)
Preferred
Bachelor’s degree in Computer Engineering, Electrical Engineering, Software Engineering, or Computer Science
Experience working through software lifecycle processes (Agile SAFe/Waterfall)
Experience with software Failure Modes Effect Analysis (sFMEA), Security Risk Assessments, defect management, software testing, and/or verification/validation
Previous employment at leading technology companies such as Amazon, Google, Microsoft, or similar
Experience with regulatory agencies (FDA, MoH, TUV) and medical device regulations (820, IEC 62304/82304, 60601), including Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and/or Digital Health Systems and Telehealth Solutions
Proven ability to influence design quality across global, multidisciplinary teams
Knowledge of Application Lifecycle Management / Traceability tools

Responsibilities

Design and test prototypes and components, applying engineering principles to meet sub-system requirements and support product development
Conduct root-cause analysis and problem-solving, evaluating solutions against technical and regulatory criteria
Translate design inputs into engineering specifications, contributing to component-level and system-level architecture and documentation
Develop software components, estimate development resources, and lead code reviews to ensure alignment with design standards and best practices
Collaborate cross-functionally with R&D, Quality, Regulatory, and Marketing teams to drive project success and ensure compliance with design controls and risk management processes
Create and maintain engineering documentation, including Design History Files, in accordance with medical device regulatory standards
Demonstrate strong understanding of clinical use cases, customer needs, and product requirements to inform design decisions
Adapt quickly to new systems and processes, showing initiative, ownership, and the ability to prioritize tasks with minimal supervision

Skills

Key technologies and capabilities for this role

Software Quality AssuranceDesign AssuranceSaMDSiMDRoot Cause AnalysisCode ReviewDesign ControlsRisk ManagementDesign History FileMedical Device RegulationsPrototypingEngineering Specifications

Questions & Answers

Common questions about this position

What is the work flexibility and location requirement for this role?

This is a hybrid role requiring candidates to be within commuting distance of San Jose, CA; Orlando, FL; Portage, MI; or Fort Wayne, IN, with in-office presence required Monday through Wednesday and remote work available Thursday and Friday.

What are the required qualifications for this position?

A Bachelor’s degree in a science or engineering field is required, along with a minimum of 2+ years of experience in a highly regulated industry following cGMP and GDP regulations in areas like R&D, Quality, Software Engineering, IT, Healthcare IT, or Systems Engineering.

What preferred experience is valued for this role?

Preferred qualifications include a Bachelor’s in Computer Engineering, Electrical Engineering, Software Engineering, or Computer Science; experience with software lifecycle processes like Agile SAFe/Waterfall; sFMEA, security risk assessments, defect management, testing/V&V; prior work at companies like Amazon, Google, or Microsoft; and familiarity with FDA, medical device regulations (820, IEC 62304/82304, 60601).

What kind of collaboration is expected in this role?

The role involves cross-functional collaboration with R&D, Quality, Regulatory, and Marketing teams to drive project success and ensure compliance with design controls and risk management processes.

What makes a strong candidate for this Senior Software Quality Engineer position?

Strong candidates will have the required Bachelor’s degree and 2+ years in regulated industries, plus preferred experience in software lifecycles, risk analysis, medical device regulations, and prior roles at top tech companies, along with the ability to work independently and commute to specified locations.

Stryker

Develops and manufactures medical devices and equipment

About Stryker

Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.

Kalamazoo, MichiganHeadquarters

1941Year Founded

$423.3MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Medical & prescription plans

Supplemental health benefits

Flexible Spending accounts

Employee Assistance Program

Short-term & long-term disability

Tuition reimbursement

401(k) plan

Employee Stock Purchase Plan

Risks

Integration challenges from acquisitions may strain Stryker's resources.

Rapid tech advancements risk obsolescence of Stryker's current products.

Regulatory scrutiny on acquisitions could delay Stryker's market entry.

Differentiation

Stryker's acquisitions enhance its minimally invasive surgical solutions portfolio.

Entry into the peripheral vascular segment diversifies Stryker's market presence.

Stryker's focus on AI integration boosts diagnostic accuracy and operational efficiency.

Upsides

Growing demand for minimally invasive solutions aligns with Stryker's strategic acquisitions.

The orthopedic implants market growth benefits Stryker's expanding product line.

Stryker's acquisition of Inari Medical positions it in a high-growth vascular market.

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