Software Quality 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

About the Role

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Masimo, one of Danaher's 15+ operating companies, our work saves lives—and we're all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. Masimo is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including non-invasive measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is, Masimo innovations empower clinicians to transform patient care. When you join our team, you'll be part of a culture that’s driven by passion, challenging the status quo, and making an impact in the lives of others. Learn about the Danaher Business System which makes everything possible.

Job Summary

The Software Quality Engineer will be responsible for the development and lifecycle management of software used in medical devices by ensuring quality, cybersecurity, compliance, and effective risk management throughout the product lifecycle. This position reports to the Sr Director, Product Compliance and is part of the Quality Compliance team located in Irvine, CA and will be an on-site role.

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.

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 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.
• It would be a plus if you also possess previous experience in:
  • Experience supporting Software as a Medical Device (SaMD), embedded software, connected devices, or cybersecurity-focused products.
  • Experience with automated test tools, defect tracking systems, or application lifecycle management systems.
  • Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or equivalent certification.
  • Master’s degree in a related technical discipline.

Location & Contract

Location: Irvine, CA. On-site role.

Compensation & Benefits

The annual salary range for this role is $70,000 - $90,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable.

• Paid time off
• Medical/dental/vision insurance
• 401(k)
• Health care program
• Bonus / Incentive Pay 10% of annual base salary

Equal Opportunity Statement

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available. We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: 1-202-419-7762 or [e-mail].

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Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com.