Software Quality Engineer I (Medical Devices)

Location: On-site in Irvine, California, United States

Salary: $70,000–$90,000 annual base salary, plus target bonus/incentive pay of 10% of annual base salary.

Company

Masimo is a hirify.global operating company that develops medical monitoring technologies, sensors, patient monitors, and connectivity solutions.

What you will do

• Support software risk management, including hazard analysis, failure mode assessments, and verification of risk controls.
• Review software design and development deliverables and support verification and validation activities.
• Assess software changes for compliance with applicable domestic and international regulations and standards.
• Support cybersecurity threat modeling, security risk assessments, requirements reviews, and testing documentation.
• Review and approve requirements, architecture, risk documentation, test protocols, traceability, and validation records.
• Assist with vulnerability monitoring, assessment, and remediation tracking.

Requirements

• At least 1 year of experience in Quality Engineering, Quality Assurance, Cybersecurity, or Software Quality within a regulated industry.
• Bachelor’s degree in Computer Science, Software Engineering, Electrical Engineering, Biomedical Engineering, or a related technical discipline.
• Working knowledge of the software development lifecycle, Agile, and/or waterfall methodologies.
• Experience supporting software verification and validation activities.
• Ability to work on-site in Irvine, California.

Nice to have

• Experience with Software as a Medical Device, embedded software, connected devices, or cybersecurity-focused products.
• Experience with automated test tools, defect tracking systems, or application lifecycle management systems.
• Certified Quality Engineer, Certified Software Quality Engineer, or equivalent certification.
• Master’s degree in a related technical discipline.

Culture & Benefits

• Paid time off and medical, dental, and vision insurance.
• 401(k) benefits for eligible employees.
• Comprehensive benefits package and eligibility for bonus/incentive pay.
• Work within a quality compliance organization focused on medical technology and patient care.