Validation Engineer

Karwell Technologies

Salt lake, UT

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JOB DETAILS

SKILLS

Cross-Functional, Documentation, Equipment Validation, ISO (International Organization for Standardization), Leadership, Maintain Compliance, Manufacturing, Mechanical Engineering, Medical Equipment, Offshoring, Process Validation, Product Testing, Project Execution, Project/Program Management, Quality Metrics, Regulatory Compliance, Time Management, Validation Plan, Writing Skills

LOCATION

Salt lake, UT

POSTED

30+ days ago

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

Validation Engineer

Karwell Technologies

Salt lake, UT

About the Company

Karwell Technologies

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