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Validation Engineer - Medical Device
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Validation Engineer - Medical Device

Job Snapshot

Employment Type Full-Time
Job Type Engineering, Manufacturing
Education 4 Year Degree
Experience At least 4 year(s)
Manages Others Not Specified
Industry Medical Equipment
Required Travel Not Specified

Job Description

  • Work with cross-function resources to complete User Requirements Specification to prepare for ordering equipment
  • Prepare CPA, order equipment and manage supplier to expected timeline
  • Write and execute IQ/OQ, PQ, TMV and Software validation Protocols and Reports
  • Develop/modify work instruction and/or process sheets required for implementing equipment and submit/manage Engineering Change Request through approval
  • Train maintenance technicians, Engineers, Manufacturing Operators, etc.. about the equipment and process
  • Manage Microsoft project plan for on-time delivery of validation

Job Requirements

Bachelor's of Science in Mechanical, Electrical or Chemical Engineering and 5 to 10 years experience in specifying, purchasing and implementing equipment with software controls.. Experience participating in FDA Regulatory audits would be a plus.

The Validation Engineer must have a combination of strong, demonstrated skills including: 
  • Demonstrated technical capability in the area of specifying, buying and implementing equipment used for manufacturing Medical Devices
    • Demonstrated ability to gather customer requirements and write and equipment specification required to purchase equipment
    • Demonstrated ability to validate test methods required to validate a process
    • Demonstrated ability to write and execute IQ/OQ, PQ, Software Validation and TMV protocols and reports.
    • Demonstrated ability to characterize a simple process and identify critical process parameter
    • Ability to train junior level resources as it relates to validated equipment
  • Interpersonal skills including conflict and relationship management
  • Project management skills to effect on-time delivery to a schedule
  • Skills to work with cross-function resources to process Engineering Change Requests
  • Must be self-motivated with tangible solid contribution, a calculated assertive risk taker and change agent.

Please contact our office at 949.250.3511 or [Click Here to Email Your Resumé]
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Validation Engineer - Medical Device

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