Validation Engineer

We are looking for an experienced Validation Engineer with a strong background in the Medical Device industry to support validation and project execution activities.

Key Requirements:

• bachelor's degree in mechanical engineering
• Prior experience in the Medical Device domain (Mandatory)
• Strong knowledge of ISO 13485 and ISO 14971
• Experience with IQ, OQ, and PQ validation activities
• Validation planning, execution, and documentation
• Equipment, process, and product transfer validation experience
• Cross-functional collaboration and stakeholder management
• Experience coordinating with customers, manufacturing plants, and offshore teams
• Project Management / Project Lead experience is a plus

Responsibilities:

• Plan, lead, and coordinate validation activities
• Support validation execution for equipment, process, and product transfers
• Author and review validation protocols and reports
• Ensure compliance with regulatory and quality standards
• Drive project continuity and on-time delivery.