Lead Medical Device Validation Engineer

Katalyst CRO; Salt Lake City (UT); On-site; USD 100,000 - 140,000; Full time

Job summary

Katalyst CRO in Salt Lake City seeks an experienced R&D/Validation Engineer to lead validation activities for medical devices, ensuring alignment with ISO 13485 and ISO 14971. The role involves coordinating equipment, process, and product transfers with global teams to ensure on-time delivery.

The ideal candidate will manage IQ, OQ, PQ protocols, author validation documentation, and drive cross-functional collaboration across Quality, Production, and Engineering to resolve issues and

Qualifications

• Experience in the Medical Devices industry with regulatory exposure.
• Strong understanding of ISO 13485 and ISO 14971.
• Hands-on IQ, OQ and PQ protocol execution.
• Excellent technical writing and record-keeping skills.
• Proven ability to lead cross-functional teams and manage global stakeholders.
• Experience as a PM/PL handling full project lifecycles.

Responsibilities

• Lead and coordinate validation activities for equipment, process, and product transfers in compliance with ISO standards.
• Plan and execute validation protocols (IQ, OQ, PQ) and associated documentation.
• Author, review, and ensure traceability of validation documents.
• Collaborate with Quality, Production, Engineering to resolve issues and streamline workflows.
• Coordinate with customers, manufacturing plants, and offshore teams to ensure on-time delivery.
• Possess PM/PL capabilities to drive project milestones.

Skills

Medical Devices

Regulatory Knowledge

IQ/OQ/PQ

Technical Documentation

Cross-functional Leadership

PM/PL Lifecycle

Job description

Katalyst CRO in Salt Lake City seeks an experienced R&D/Validation Engineer to lead validation activities for medical devices, ensuring alignment with ISO 13485 and ISO 14971. The role involves coordinating equipment, process, and product transfers with global teams to ensure on-time delivery.

The ideal candidate will manage IQ, OQ, PQ protocols, author validation documentation, and drive cross-functional collaboration across Quality, Production, and Engineering to resolve issues and