Software Quality Engineer - Medical Device Software Development

The Software Quality Engineer will provide quality leadership on cross-functional product development teams responsible for developing regulated medical device software systems. This individual will serve as a subject matter expert in software quality, requirements management, software risk management, verification and validation strategy, design controls, and defect management throughout the software development lifecycle., * Support the design, development, verification, and validation of regulated medical device software, including Software as a Medical Device (SaMD).

• Provide technical leadership and guidance on software development processes, quality systems, and best practices.

• Partner with engineering teams to refine software requirements and ensure architecture and design documentation is complete and compliant.

• Facilitate documentation and tracking of software verification activities, including code review findings and testing results.

• Review software test execution results, manage software defects, and support root cause investigations.

• Lead software risk assessment activities and develop software risk management documentation.

• Support regulatory submissions, product registrations, and compliance documentation.

• Support internal and external quality audits and regulatory inspections related to software products and quality systems.

• Manage nonconformances, CAPAs, and corrective actions associated with software development activities.

• Provide technical support for software supplier and third-party software development audits.

• Deliver training on software development processes, quality systems, and applicable regulatory requirements.

• Mentor junior engineers and provide guidance on software quality engineering best practices.

• Ensure compliance with applicable software and medical device standards, including:

• IEC 62304

• ISO 13485

• ISO 14971

• IEC 62366

• FDA Software Guidance

• FDA 21 CFR Part 11

• EU MDR

• ISO 27001

• HIPAA

Ensure software products meet cybersecurity, privacy, electronic protected health information (ePHI), and personally identifiable information (PII) protection requirements.

Collaborate with cross-functional teams to ensure compliance with company quality systems, policies, and applicable regulatory requirements.

Communicate project risks, quality issues, and opportunities to leadership as appropriate.

Follow all health, safety, environmental, and quality procedures.

Perform additional responsibilities as assigned.

• Bachelor's degree in Engineering, Computer Science, Information Systems, Biomedical Engineering, or a related technical discipline required.
• Minimum of four years of experience in a regulated industry within software quality, quality engineering, new product development, or manufacturing engineering.
• Experience supporting software development within a regulated medical device environment.
• Demonstrated understanding of software quality systems, design controls, software verification and validation, and risk management.
• Experience applying quality tools, processes, and methodologies to support product development., * Strong understanding of the medical device software development lifecycle.
• Experience with Software as a Medical Device (SaMD) development preferred.
• Knowledge of software risk management, design controls, software verification and validation, defect management, and CAPA processes.
• Familiarity with FDA and international medical device regulations and standards.
• Strong analytical, organizational, and problem-solving skills.
• Excellent written and verbal communication skills.
• Ability to work effectively on cross-functional engineering teams.
• Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.
• ASQ Certified Software Quality Engineer (CSQE) or equivalent certification is preferred.