Senior Validation Engineer

Katalyst-Healthcares-; City of Rochester (NY); On-site; USD 90,000 - 130,000; Full time

Job summary

JobDiva, Inc. seeks an experienced R&D/Validation Engineer in the Medical Devices sector to plan, lead, and coordinate validation activities in strict alignment with ISO 13485 and ISO 14971 standards.

The role requires hands-on leadership to manage equipment, process, and product transfers while liaising with global teams and customers to ensure on-time delivery.

Qualifications

• Must have prior experience in Medical Devices domain.
• Deep understanding of ISO 13485 and ISO 14971.
• Hands-on validation experience with IQ/OQ/PQ for equipment and process transfers.

Responsibilities

• Plan, lead, and coordinate validation activities ensuring compliance with ISO standards.
• Execute validation planning and protocols for equipment, process, and product transfers (IQ/OQ/PQ).
• Author, review, and approve validation documentation with traceability to QMS.
• Coordinate with cross-functional teams and global stakeholders to ensure timely delivery and issue resolution.

Skills

Medical devices domain

Regulatory knowledge ISO 13485/14971

IQ/OQ/PQ validation

Technical writing

PM/PL leadership

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.