MedTech CSV Engineer — Software Assurance (Remote)

Danaher Corporation; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Masimo, a Danaher operating company, seeks an experienced Engineer to lead Computer System Validation strategy and oversight for GxP systems including ERP, QMS, MES, and manufacturing software. You will ensure compliance with FDA, ISO, and global requirements, including 21 CFR Part 11 and Part 820, while enabling robust system implementations.

The role emphasizes documentation, data integrity, and collaboration across teams, with potential remote work arrangements.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Computer System Validation

Regulatory compliance

GxP experience

Documentation

IQ/OQ/PQ

Data integrity

Audit readiness

System security

Job description

Masimo, a Danaher operating company, seeks an experienced Engineer to lead Computer System Validation strategy and oversight for GxP systems including ERP, QMS, MES, and manufacturing software. You will ensure compliance with FDA, ISO, and global requirements, including 21 CFR Part 11 and Part 820, while enabling robust system implementations.

The role emphasizes documentation, data integrity, and collaboration across teams, with potential remote work arrangements.