Software Quality Engineer II (MedTech)

TL;DR

Software Quality Engineer II (MedTech): Supporting the development and lifecycle management of medical device software with an accent on quality, compliance, and risk management. Focus on reviewing design deliverables, conducting verification and validation, and ensuring adherence to global regulatory standards.

Location: Must be based in or be able to work onsite in Irvine, CA, United States

Salary: $75,000 - $100,000

Company

A medical technology company specializing in non-invasive monitoring and medical device software.

What you will do

• Partner with software development and cross-functional teams to integrate quality into the SDLC.
• Review and approve requirements, architecture, risk documentation, test protocols, and validation records.
• Ensure compliance with regulatory standards including FDA 21 CFR Part 820, ISO 13485, IEC 62304, and ISO 14971.
• Evaluate software defects, nonconformances, and quality events to determine product impact.
• Participate in CAPA, complaint investigations, and post-market surveillance activities.
• Drive continuous improvement initiatives to strengthen software quality systems and compliance.

Requirements

• Bachelor’s degree in Computer Science, Software Engineering, Electrical/Biomedical Engineering, or a related field.
• Minimum 3 years of experience in Quality Engineering or QA within a regulated industry.
• Working knowledge of SDLC, Agile, and waterfall development methodologies.
• Experience supporting software verification and validation (V&V) activities.
• Knowledge of medical device standards (FDA 21 CFR Part 820, ISO 13485, IEC 62304, ISO 14971).
• Must be based in or be able to work onsite in Irvine, CA, USA

Nice to have

• Experience with Software as a Medical Device (SaMD), embedded software, or cybersecurity products.
• Experience with automated test tools, defect tracking, or ALM systems.
• CQE or CSQE certification.
• Master’s degree in a related technical discipline.

Culture & Benefits

• Comprehensive health coverage including Medical, Dental, and Vision.
• Financial perks including a 401(k) and up to 10% annual performance bonus.
• Paid time off: Vacation, Sick leave, and Paid Maternity Leave.
• Life/AD&D and Disability Insurance, plus Flexible Spending Accounts.
• On-site facilities: Wellness Clinic, Fitness Center, and Café.