Onsite Medical Device Software QA Engineer I

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

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Bonus / Incentive Pay 10% of annual

Job summary

Masimo in Irvine, CA, is seeking a Software Quality Engineer to drive quality and cybersecurity across the software lifecycle for medical devices. This on-site role reports to the Sr Director, Product Compliance within the Quality Compliance team.

You will oversee risk management, verify and validate software, and ensure regulatory compliance across domestic and international standards. Collaboration with design, engineering, and cybersecurity teams is essential to deliver safe, reliable medical

Qualifications

• Bachelor’s degree in Computer Science, Software Engineering, Electrical Engineering, Biomedical Engineering, or related technical discipline.
• Working knowledge of software development lifecycle (SDLC), Agile and/or waterfall development methodologies.
• Experience supporting software verification and validation activities.

Responsibilities

• Support software risk management activities, including hazard analysis, failure mode assessments, and risk control verification.
• Review software design and development deliverables, support verification and validation activities, assess software changes, and ensure compliance with applicable domestic and international regulations and standards.
• Support cybersecurity threat modeling and security risk assessment, review cybersecurity requirements and testing documentation, and assist with vulnerability monitoring, assessment and remediation tracking.
• Review and approve software development deliverables, including requirements, architecture, risk documentation, test protocols, traceability, and validation records.
• Perform other duties or special projects as assigned.

Skills

Quality engineering

Cybersecurity

Risk management

SDLC knowledge

Regulated industry

Education

Bachelor’s degree in CS/EE/Biomedical

Master’s degree in related discipline

CQE/CSQE certification

Tools

Automated test tools

Defect tracking

ALM systems

Job description

Masimo in Irvine, CA, is seeking a Software Quality Engineer to drive quality and cybersecurity across the software lifecycle for medical devices. This on-site role reports to the Sr Director, Product Compliance within the Quality Compliance team.

You will oversee risk management, verify and validate software, and ensure regulatory compliance across domestic and international standards. Collaboration with design, engineering, and cybersecurity teams is essential to deliver safe, reliable medical