Software Design Quality Assurance Engineer

Position Overview

We are seeking an experienced Software Design Quality Assurance Engineer to support the development and sustaining of complex medical device products. This consultant will partner closely with Software, Firmware, Systems Engineering, R&D, Quality, Regulatory, and other cross-functional teams to ensure compliant execution of design controls, risk management, and software lifecycle activities.

The ideal candidate will have a strong hands-on Software Design Quality/Design Assurance background within the medical device industry, with experience supporting software-driven Class II and/or Class III products.

Key Responsibilities

• Provide hands-on Software Design Quality Assurance support throughout the product lifecycle, including new product development and sustaining activities.

• Partner directly with Software, Firmware, Systems Engineering, and R&D teams on design quality activities.

• Review software requirements, specifications, design documentation, design reviews, and verification/validation documentation.

• Support compliance with IEC 62304 software lifecycle requirements and applicable FDA regulations and quality system requirements.

• Execute and support ISO 14971 risk management activities specific to software and system-level risks.

• Develop and/or review software hazard analyses, Software FMEAs, risk assessments, and risk controls.

• Establish and maintain traceability between user needs, system/software requirements, hazards, risk controls, and V&V evidence.

• Evaluate software and system changes and perform design change impact assessments.

• Support software/hardware/firmware integration activities and assess associated quality and risk considerations.

• Participate in design reviews, verification readiness assessments, product release activities, and regulatory submissions as needed.

• Support CAPA, nonconformance, complaint, and post-market activities involving software or system-level product risks.

• Review and assess design documentation for compliance, completeness, and appropriate risk-control implementation.

• Support audit and inspection readiness by ensuring appropriate software design assurance documentation and traceability.

Required Qualifications

• Bachelor's degree in Engineering, Computer Science, Biomedical Engineering, or a related technical discipline.

• 7+ years of experience in medical device Software Quality, Software Design Assurance, or Software Design Quality.

• Strong hands-on experience with IEC 62304.

• Experience applying ISO 14971 to software and/or system-level risk management.

• Experience with cybersecurity risk management/design assurance for medical devices.

• Experience with software requirements, design controls, traceability, and V&V.

• Experience developing or reviewing software hazard analyses, Software FMEA, and risk controls.

• Experience working directly with Software Engineering and Systems Engineering teams.

• Strong understanding of FDA medical device quality requirements and ISO 13485.

• Experience supporting commercial or development-stage medical devices.

Preferred Qualifications

• Experience with hardware/software/firmware integration.

• Experience with IEC 62366 / usability engineering.

• Experience supporting Class II and/or Class III medical devices.

• Experience with FDA submissions and regulatory interactions.

• Experience with sustaining engineering and product lifecycle activities.

• West Coast based candidates preferred.