Job Title: Medical Device Validation Engineer
Location: Mentor, OH (Onsite)
Experience: 3 - 5 Years
Industry: Medical Devices
Job Summary
We are seeking a Medical Device Validation Engineer with a strong background in equipment and process validation within regulated industries. This role is responsible for developing, executing, and reviewing validation protocols to ensure compliance with FDA, GMP, and ISO 13485 standards.
Key Responsibilities
Develop, execute, and review validation protocols and reports (IQ/OQ/PQ).
Support new equipment installation, process validation, and change control activities.
Conduct test method validation, equipment qualification, and related activities.
Ensure validation deliverables meet FDA, GMP, and ISO 13485 compliance requirements.
Partner with cross-functional teams on validation activities for equipment, processes, and laboratory systems.
Maintain accurate documentation and support audits/inspections.
Contribute to continuous improvement initiatives in validation and quality systems.
Requirements
Bachelor's degree in Engineering, Life Sciences, or related technical field.
3 5+ years of validation engineering experience in medical device, pharmaceutical, or other FDA-regulated industry.
Strong knowledge of FDA, GMP, and ISO 13485 validation requirements.
Hands-on experience with IQ/OQ/PQ, equipment qualification, and test method validation.
Familiarity with sterilization processes, cleaning validation, or laboratory equipment validation preferred.
Excellent documentation, technical writing, and problem-solving skills.
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