We are looking for an experienced Validation Engineer with a strong background in the Medical Device industry to support validation and project execution activities. Experience coordinating with customers, manufacturing plants, and offshore teams.
Numbers & Facts
Location
Salt lake, UT
Description
Job Description:
We are looking for an experienced Validation Engineer with a strong background in the Medical Device industry to support validation and project execution activities.
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.
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