Medical Devices Manufacturing Process ValidationJob Responsibilities:Assist on Coordinating and Supports Suppliers for Manufacturing of Custom Equipment/ToolingAssist on Coordinates purchase and delivery of Equipment/ToolingAssist on Coordinates installation of Equipment/ToolingSupport on Developing and Executing IQ and OQ Protocols and ReportsSupport on Developing and Executing Test Method Validations / Gage R&RSupport on Generating nd Issues for Approval of SOPs and Manufacturing ProceduresSupport on Developing and Executing Component QualificationsSupport on Developing and Executing PQ and PPQ Protocols and ReportsSupport on Developing Manufacturing Capacity AnalysisSupport on Developing and Executing Process Characterizations / Design of Experiments (DOE)Support on Developing documentation/justification for assigned capital projectsSupport on Complying with cGMP's, Quality Standards, and established policies and proceduresSupport on Executing other duties assigned by his Process Validation Lead & other supervisorsQualifications Knowledge and Skills:Bachelor's degree in engineeringExperience in the Medical Device Industries with experience in the Manufacturing Process ValidationDemonstrates excellent written and verbal communication skills (English and Spanish) across all levels.Qualification / Validation (IQ/OQ/PQ)Test Method Validation / Gage R&RProcess Characterization / Design of Experiments (DOE)Manufacturing Line Design / Capacity AnalysisEquipment / Tooling DesignEquipment Installation / Preventive Maintenance Procedure GenerationRoot Cause Analysis / InvestigationSOP / Manufacturing Procedures Generation & Change ControlProduct Financials & Supply Chain Structure DesignOEE Integration, Vertical Start up and Zero-loss mindsetRequired Education and Experience:Requires a bachelor's degree in engineering or related field with minimum 3 years of experience in an engineering role OR MS with at least 2 year of experience in an engineering role.