Engineer, Computer Software Assurance

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.