Senior Validation Engineer / Project Lead (Medical Devices)

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

Summary

We are seeking a highly skilled R&D/Validation Engineer with mandatory experience in the Medical Devices domain. The ideal candidate will be responsible for planning, leading, and coordinating project execution and validation activities in strict alignment with ISO 13485 and ISO 14971 standards. This role requires a hands-on leader who can manage equipment, process, and product transfers while liaising with global teams and customers to ensure on-time delivery.

Roles & Responsibilities

• Project Leadership: Plan, lead, and coordinate project execution and validation activities, ensuring compliance with regulatory standards (ISO 13485, ISO 14971).
• Validation Execution: Support and execute validation planning and protocols for equipment, process, and product transfers, specifically managing IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
• Documentation & Compliance: Author, review, and approve validation documentation, ensuring traceability and adherence to quality system regulations. Cross-Functional Collaboration: Collaborate effectively with cross-functional teams (Quality, Production, Engineering) to resolve technical issues and streamline project workflows.
• Stakeholder Coordination: Act as the primary point of contact, coordinating with customers, manufacturing plants, and off-shore teams to ensure project continuity and timely delivery. Strategic Contribution: Contribute as a Project Manager (PM) or Project Lead (PL) to drive project milestones is an added advantage.

Skills & Qualifications

• Domain Expertise: Mandatory prior experience in the Medical Devices industry. Regulatory Knowledge: Deep understanding of "ISO 13485" (Quality Management) and "ISO 14971" (Risk Management).
• Validation Expertise: Proven hands-on experience with IQ, OQ, and PQ protocols for equipment and process transfers.
• Documentation: Strong technical writing skills for authoring and reviewing validation protocols/reports.
• Coordination: Proven ability to manage cross-functional teams and global stakeholders (offshore and onshore).
• Experience as a PM/PL handling full project lifecycles.