Job Summary:
Masimo is a company focused on the development and lifecycle management of software for medical devices. The Software Quality Engineer II role involves ensuring quality and compliance throughout the product lifecycle while collaborating with various engineering and regulatory teams.
Responsibilities:
โข Partner with software development and cross-functional teams to ensure quality is integrated throughout the software development lifecycle.
โข Review and approve software development deliverables including requirements, architecture, risk documentation, test protocols, traceability, and validation records.
โข Support design control activities in compliance with applicable regulations and standards, including FDA 21 CFR Part 820, ISO 13485, IEC 62304, ISO 14971, and other applicable global requirements.
โข Participate in design reviews, phase gate reviews, and change control activities for software-based products and systems.
โข Review software verification and validation activities including unit, integration, system, cybersecurity, and user acceptance testing.
โข Support software risk management activities, including hazard analysis, failure mode assessments, and risk control verification.
โข Evaluate software defects, nonconformances, and quality events to determine product impact and required actions.
โข Participate in CAPA, complaint investigations, post-market surveillance, and field issue assessments involving software-related products.
โข Support internal audits, external audits, and regulatory inspections by preparing documentation and providing subject matter expertise.
โข Drive continuous improvement initiatives to strengthen software quality systems, processes, and compliance effectiveness.
โข Assist in the creation, review, and maintenance of Design History Files (DHF), Device Master Records (DMR), and quality records.
โข Mentor junior team members and provide guidance on software quality processes and best practices as needed.
โข Perform other duties or special projects as assigned.
Qualifications:
Required:
โข Bachelorโs degree in Computer Science, Software Engineering, Electrical Engineering, Biomedical Engineering, or related technical discipline.
โข Minimum 3 years of experience in Quality Engineering, Quality Assurance, or Software Quality within a regulated industry.
โข Working knowledge of software development lifecycle (SDLC), Agile and/or waterfall development methodologies.
โข Experience supporting software verification and validation activities.
โข Knowledge of medical device regulations and standards such as FDA 21 CFR Part 820, ISO 13485, IEC 62304, and ISO 14971.
โข Experience with change control, nonconformance, CAPA, and complaint handling processes.
โข Strong analytical, problem-solving, and risk assessment skills.
โข Strong written and verbal communication skills with the ability to work cross-functionally.
โข Proficiency with Microsoft Office applications and quality documentation systems.
โข Ability to read, write, and communicate effectively in English.
โข Ability to interpret technical documents, schematics, and written instructions.
โข Ability to clearly document technical findings and communicate with cross-functional team members.
Preferred:
โข Experience supporting Software as a Medical Device (SaMD), embedded software, connected devices, or cybersecurity-focused products.
โข Experience with automated test tools, defect tracking systems, or application lifecycle management systems.
โข Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or equivalent certification.
โข Experience in the medical device industry strongly preferred.
โข Masterโs degree in a related technical discipline.
Company:
Masimo is a medical technology company that develops and manufactures noninvasive patient monitoring devices for healthcare settings. It is a sub-organization of Danaher. Founded in 1989, the company is headquartered in Irvine, USA, with a team of 1001-5000 employees. The company is currently Late Stage.