Software Quality Engineer I

Danaher•Irvine, CA

1d•$70,000 - $90,000•Onsite

About The Position

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. In this role, you will have the opportunity to support software risk management activities, including hazard analysis, failure mode assessments, and risk control verification. You will also 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. Additionally, you will support cybersecurity threat modeling and security risk assessment, review cybersecurity requirements and testing documentation, and assist with vulnerability monitoring, assessment and remediation tracking. You will review and approve software development deliverables, including requirements, architecture, risk documentation, test protocols, traceability, and validation records. Other duties or special projects may be assigned.

Requirements

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.

Nice To Haves

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.

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.