Jobs at Danaher Corporation

The Engineer, Computer Software Assurance at Masimo (a Danaher operating company) is responsible for ensuring that computerized systems used in GxP processes at Masimo comply with global regulatory requirements. This role provides strategic oversight of CSV activities across the organization, ensuring compliance with FDA, ISO, and global regulations while enabling efficient and robust system implementations.

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. This position is eligible for a remote work arrangement.

• Lead, develop, and execute comprehensive Computer System Validation (CSV) strategies, plans, and protocols (IQ/OQ/PQ) in compliance with FDA and global regulatory requirements.
• Oversee validation activities for GxP-regulated computerized systems including ERP, QMS, MES, manufacturing equipment software, data integrity systems, and custom applications.
• Ensure systems meet 21 CFR Part 820, 21 CFR Part 11, and ISO 13485 requirements for software validation and electronic records/electronic signatures.

Essential requirements:

• 5+ years of experience in Computer System Validation within a regulated medical device, pharmaceutical, or biotechnology environment preferred.
• Advanced knowledge of and hands-on experience with: 21 CFR Part 11, Part 820, ISO 13485, ISO 14971, GAMP5 guidelines, FDA guidance on risk-based software validation and computer software assurance.
• Proven leadership in planning, executing, and documenting validation of enterprise and manufacturing systems.
• Strong understanding of data integrity requirements, audit trails, and system security principles.
• Experience developing validation documentation including URS, design specifications, traceability matrix, validation plans, IQ/OQ/PQ, summary reports, and controlled procedures.
• Excellent analytical, technical writing, and communication skills.
• Ability to travel as needed.

It would be a plus if you also possess previous experience in:

• Familiarity with: EU MDR, Annex 11 (EU guidelines on computerized systems) and ISO 27001 (Information Security Management).
• Hands-on experience with validation of cloud-based or SaaS systems.
• Prior experience supporting FDA and Notified Body inspections as a CSV subject matter expert.
• Experience developing or enhancing CSV/QMS processes.