Senior Software Quality Engineer, Design Assurance

Stryker; San Jose (CA); Hybrid; USD 89,000 - 149,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Employee Stock Purchase Plan (ESPP)

Job summary

Stryker is hiring a Senior Software Design Quality Engineer to support Digital Health projects as a software quality assurance engineer for pre-market product development. The role is hybrid, requiring commuting to San Jose, CA or Orlando, FL, with in-office presence 3 days a week.

You will design software components, lead root-cause analyses, and ensure traceability to regulatory standards, collaborating across R&D, Quality, Regulatory, and Marketing to meet patient safety and product quality

Qualifications

• Bachelor’s degree in a science or engineering.
• Minimum of 2+ years of experience in R&D, Quality Engineering, Software Quality Engineering, IT or Systems Engineering.
• Experience in highly regulated industries with compliance standards (cGMP, GDP, or equivalent).

Responsibilities

• Design software components and system elements to meet requirements and quality standards.
• Lead analytical problem-solving and evaluate design options against constraints to drive robust solutions.
• Translate design inputs into engineering specifications and contribute to architecture and documentation.
• Develop software modules, provide estimates, and participate in design and code reviews for quality.
• Collaborate with R&D, Quality, Regulatory, and Marketing to align design decisions with strategy and user needs.
• Create and maintain Design History File elements with traceability and regulatory compliance.
• Stay informed about clinical workflows and customer needs to guide design and usability.
• Adapt to new tools and processes, showing initiative and prioritization with minimal supervision.

Education

Bachelor’s degree in a science or engineering

Bachelor’s degree in Computer Engineering, Electrical Engineering, Software Engineering, or Computer Science

Job description

Stryker is hiring a Senior Software Design Quality Engineer to support our Medical's SmartCare division and portfolio Software as a Medical Device (SiMD) or Software in a Medical Device (SiMD) to execute on Digital Health projects as a software design quality assurance engineer for pre-market new product development projects.

Workplace Flexibility & Location requirements

This is a hybrid role requiring the candidate to be within commuting distance of one of the following locations: San Jose, CA or Orlando, FL. The work schedule is structured to support flexibility, with in-office presence required 3 days/week and remote work available the rest of the week. To qualify, candidates must be able to commute to one of these specific facilities as needed.

What you will do

• Design software components and system elements, applying strong engineering and design principles to meet sub‑system requirements and support scalable, high‑quality product development.
• Lead analytical problem‑solving activities, identifying root causes and evaluating design options against technical, user, and regulatory constraints to drive robust solutions.
• Translate design inputs into clear engineering specifications, contributing to both component‑level and system‑level architecture and high‑quality technical documentation.
• Develop software modules and contribute to architectural planning, providing effort estimates and facilitating design and code reviews to ensure alignment with quality standards and engineering best practices.
• Collaborate with R&D, Quality, Regulatory, and Marketing, ensuring design decisions align with product strategy, user needs, and medical device design control requirements.
• Create and maintain comprehensive engineering documentation, including Design History File elements, ensuring traceability, compliance, and long‑term maintainability.
• Stay deeply informed about clinical workflows, customer needs, and operational requirements, using this understanding to guide design choices and enhance product usability and safety.
• Adapt quickly to new tools, systems, and processes, demonstrating initiative, ownership, and the ability to manage priorities effectively with minimal oversight.

What you need

Required

• Bachelor’s degree in a science or engineering.
• Minimum of 2+ years of experience working in the areas of Research & Development (R&D), Quality Engineering, Software Quality Engineering, Information Technology, Healthcare IT or Systems Engineering.
• Proven experience working in either leading technology company or highly regulated industries, ensuring adherence to cGMP, GDP, or relevant compliance standards.

Preferred

• Bachelor’s degree in Computer Engineering, Electrical Engineering, Software Engineering, or Computer Science.
• Demonstrated ability to operate within various software development lifecycle models, including Agile SAFe or Waterfall.
• Experience with software Failure Modes Effect Analysis (sFMEA), Security Risk Assessments and defect management, software testing and/or verification/validation.
• 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.

United States of America Pay Ranges

• USN: $89,300 - $148,800 USD Annual
• US30: $116,100 - $193,400 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.