Engineer, Computer Software Assurance

Danaher Corporation; United States; Remote; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Computer System Validation

Regulatory compliance

GxP experience

Documentation

IQ/OQ/PQ

Data integrity

Audit readiness

System security

Jobbeschreibung

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.

The Engineer, Computer Software Assurance 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.

In this role, you will have the opportunity to:

• 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.

The essential requirements of the job include

• 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.

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• 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.

Masimo, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

At Masimo we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home.

Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Masimo can provide.

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.