Software Quality Engineer I - MedTech & SaMD

Masimo Corporation; Irvine (CA); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Benefits package

Job summary

Masimo Corporation in Irvine, CA is seeking a Software Quality Engineer to drive quality, cybersecurity, and risk management for medical device software across the product lifecycle. You will report to the Sr Director, Product Compliance and work on-site in Irvine.

Responsibilities include risk management, design and validation reviews, cybersecurity testing, and ensuring compliance with domestic and international regulations.

Qualifications

• 1+ years of experience in Quality Engineering, Quality Assurance, Cybersecurity, or Software Quality within a regulated industry.
• Bachelor’s degree in Computer Science, Software Engineering, Electrical, Biomedical Engineering, or related technical discipline.
• Working knowledge of software development lifecycle (SDLC) and Agile or waterfall methodologies.
• Experience supporting software verification and validation activities.

Responsibilities

• Support software risk management activities, including hazard analysis and risk control verification.
• Review software design, verification/validation activities, and ensure regulatory compliance.
• Support cybersecurity threat modeling, testing documentation, and vulnerability remediation tracking.
• Review and approve software development deliverables, including requirements, architecture, risk docs, tests, and validation records.
• Perform other duties or special projects as assigned.

Skills

Quality Engineering

Quality Assurance

Cybersecurity

Software Quality

SDLC knowledge

Agile methodologies

Education

Bachelor's degree in Computer Science/Software Engineering/Electrical/Biomedical Engineering

Master's degree (nice-to-have)

Tools

Automated test tools

Defect tracking systems

ALM/Requirements management

Job description

Masimo Corporation in Irvine, CA is seeking a Software Quality Engineer to drive quality, cybersecurity, and risk management for medical device software across the product lifecycle. You will report to the Sr Director, Product Compliance and work on-site in Irvine.

Responsibilities include risk management, design and validation reviews, cybersecurity testing, and ensuring compliance with domestic and international regulations.