Validation Engineer

No H1B , relocation is workablePosition SummarySeeking an Associate Validation Engineer to support medical device validation activities within a manufacturing and remediation environment. This role will support process validation, test method validation, inspection validation, and equipment qualification activities while working closely with Quality, Engineering, Manufacturing, and Operations teams.The ideal candidate will possess a strong engineering foundation (Electrical or Mechanical) along with hands-on experience supporting validation activities within a regulated medical device environment.ResponsibilitiesExecute IQ, OQ, and PQ protocolsSupport process validation and equipment qualification activitiesDevelop and execute test method validation (TMV) protocolsSupport inspection method validation activitiesAssist with validation protocol generation, execution, and reportingSupport root cause investigations associated with validation activitiesReview and analyze validation dataCollaborate with Quality, Manufacturing, and Engineering teamsSupport remediation and continuous improvement initiativesMaintain validation documentation in accordance with FDA and ISO requirementsRequired QualificationsBachelor's degree in Engineering (Electrical or Mechanical preferred)5-8 years of medical device validation experienceExperience with:IQ/OQ/PQProcess ValidationTest Method Validation (TMV)Inspection Method ValidationWorking knowledge of FDA Quality System requirementsStrong technical writing and documentation skillsPreferred QualificationsElectrical OpeningElectrical Engineering backgroundElectronics manufacturing experienceSoldering experienceInspection equipment validationMechanical OpeningMechanical Engineering backgroundManufacturing process validation experiencePrior soldering experienceAssembly process validation