Stryker ยท 22 hours ago
Senior Software Quality Engineer, Design Assurance
Orlando, FL
Full-time
Hybrid
Mid, Senior Level
$89K/yr - $193K/yr
2+ years expStryker is hiring a Senior Software Quality Engineer, Design Assurance to support their Medical's Digital Health division and portfolio Software as a Medical Device. The role involves executing on Digital Health projects as a software design quality assurance engineer for pre-market new product development projects.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Designed and tested prototypes and components, applying engineering principles to meet sub-system requirements and support product development
Conducted root-cause analysis and problem-solving, evaluating solutions against technical and regulatory criteria
Translated design inputs into engineering specifications, contributing to component-level and system-level architecture and documentation
Developed software components, estimated development resources, and led code reviews to ensure alignment with design standards and best practices
Collaborated cross-functionally with R&D, Quality, Regulatory, and Marketing teams to drive project success and ensure compliance with design controls and risk management processes
Created and maintained engineering documentation, including Design History Files, in accordance with medical device regulatory standards
Demonstrated strong understanding of clinical use cases, customer needs, and product requirements to inform design decisions
Adapted quickly to new systems and processes, showing initiative, ownership, and the ability to prioritize tasks with minimal supervision
Qualification
Required
Bachelor's degree in a science or engineering
Minimum of 2+ years of experience working in a highly regulated industry in following cGMP and GDP regulations in the areas of Research & Development (R&D), Quality (QA/QC), Software Engineering, Information Technology, Healthcare IT or Systems Engineering
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 and defect management, software testing and/or verification/validation
Previous employment at leading technology companies such as Amazon, Google, Microsoft, or similar, demonstrating strong technical skills
Experience with regulatory agencies (FDA, MoH, TUV) and medical device regulations (820, IEC 62304/82304, 60601), with experience in Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and/or Digital Health Systems and Telehealth Solutions
Knowledge from using Application Lifecycle Management /Traceability tools
Benefits
Medical and prescription drug insurance
Dental insurance
Vision insurance
Critical illness insurance
Accident insurance
Hospital indemnity insurance
Personalized healthcare support
Wellbeing program
Tobacco cessation program
Health Savings Account (HSA)
Flexible Spending Accounts (FSAs)
401(k) plan
Employee Stock Purchase Plan (ESPP)
Basic life and AD&D insurance
Short-term disability insurance
Company
Stryker
Stryker is a medical technology company that offers products and services in orthopaedics.
10001+ employees
H1B Sponsorship
Stryker has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (105)
2024 (76)
2023 (63)
2022 (78)
2021 (57)
2020 (77)
Funding
Current Stage
Public CompanyTotal Funding
unknown1990-01-02IPO
Leadership Team
Kevin Lobo
Chair & CEO
Glenn S. Boehnlein
Chief Financial Officer and Vice President
Recent News
GlobeNewswire News Room
2025-02-11
Company data provided by crunchbase