Senior Software Quality Engineer — Medical Device Design

Lancesoft; Irvine (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Lancesoft in Irvine, CA is seeking a Senior Software Quality Engineer to join the Neurovascular Pre-Market Design Quality team. You will work onsite with cross-functional teams to ensure software and system design activities comply with design controls, risk management, and regulatory requirements for medical devices.

The role emphasizes sizing software within the design control lifecycle. The ideal candidate combines systems engineering and software development knowledge with experience in V&V,

Qualifications

• Bachelor's degree in Software/Computer/Electrical/Systems Engineering with 4+ years of experience (or advanced degrees with fewer years).
• Experience with design controls and software lifecycle activities.
• Strong risk management and traceability across requirements, design, and testing.

Responsibilities

• Provide design quality support for software and medical device development.
• Ensure design controls, software lifecycle, and risk management compliance.
• Review system and software requirements, architecture, and design docs.
• Support verification and validation strategies for software and system.
• Collaborate with cross-functional teams to resolve quality issues.
• Perform root cause analysis and oversee corrective actions.
• Mentor junior engineers on design quality and regulatory requirements.
• Contribute to continuous improvement of quality processes.

Skills

Software Quality

Design Controls

Regulatory Compliance

Risk Management

Verification & Validation

Cross-functional Collaboration

Communication

Education

Bachelor's degree in Software/Computer/Electrical/Systems Engineering

Master's degree

PhD

Job description

Lancesoft in Irvine, CA is seeking a Senior Software Quality Engineer to join the Neurovascular Pre-Market Design Quality team. You will work onsite with cross-functional teams to ensure software and system design activities comply with design controls, risk management, and regulatory requirements for medical devices.

The role emphasizes sizing software within the design control lifecycle. The ideal candidate combines systems engineering and software development knowledge with experience in V&V,