Senior Medical Device Software QA Engineer

Redbock - an NES Fircroft company; United States; On-site; USD 120,000 - 160,000; Full time

Job summary

Redbock - an NES Fircroft company seeks an experienced Software Design Quality Assurance Engineer to support development and sustaining of complex medical device products. You will partner with Software, Firmware, Systems Engineering, R&D, Quality, and Regulatory teams to ensure compliant design controls, risk management, and software lifecycle activities.

You will bring hands-on IEC 62304 experience and a track record with Class II/III medical devices, contributing to design reviews, V&V, risk

Qualifications

• Bachelor's degree in Engineering, Computer Science, Biomedical Engineering, or 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.

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.

Skills

IEC 62304

Software QA

Risk management

V&V

Traceability

Regulatory submissions

Cybersecurity risk

Education

Bachelor's degree in Engineering or related field

Job description

Redbock - an NES Fircroft company seeks an experienced Software Design Quality Assurance Engineer to support development and sustaining of complex medical device products. You will partner with Software, Firmware, Systems Engineering, R&D, Quality, and Regulatory teams to ensure compliant design controls, risk management, and software lifecycle activities.

You will bring hands-on IEC 62304 experience and a track record with Class II/III medical devices, contributing to design reviews, V&V, risk