Senior Software Quality Engineer, Design Assurance

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.

Responsibilities

• 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.

Requirements

• 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.

Qualifications

• 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.

Pay

United States of America Pay Ranges:

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

Benefits

Health benefits

• 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

• 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