LL01-251009 Sr Engineer for Medical Devices
hace 2 semanas
LL Sr Engineer for Medical Devices Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Sr. Engineer for Medical Devices Summary of Position with General Responsibilities: Leads the technical support to new product transfers and/or product development projects. Possesses technical responsibility for interpreting, planning, organizing, executing, coordinating, and carrying out technical assignments based on diversified requirements. Essential Job Functions: Coordinates and Supports Suppliers for Manufacturing of Custom Equipment/Tooling Coordinates purchase and delivery of Equipment/Tooling Coordinates installation of Equipment/Tooling Develops and Executes IQ and OQ Protocols and Reports Develops and Executes Usage Requirements Specifications and Factory Acceptance Tests Develops and Executes Test Method Validations / Gage R&R Generates and Issues for Approval SOPs and Manufacturing Procedures Develops and Executes Component Qualifications Develops and Executes PQ and PPQ Protocols and Reports Designs / Coordinates Facilities Modifications Creates / Coordinates Manufacturing Line Layout Develops Manufacturing Capacity Analysis Designs Equipment and Tooling Develops and Executes Process Characterizations / Design of Experiments (DOE) Develops and Maintains Project Timeline / Plan Develops documentation/justification for assigned capital projects Complies with cGMP’s, Quality Standards, and established policies and procedures Executes other duties assigned by his supervisor Basic Qualifications: Bilingual - English and Spanish (oral and written) Technical writing skills GMP, ISO, EHS and Statistical regulations knowledge Strong Computer Skills/Knowledge (Word, Excel, PowerPoint) MS Project knowledge Minitab Proficiency Additional Desirable Qualifications Skills and Knowledge: Engineering Post Graduate Degree (Masters / PhD) Lean / Six sigma Training/Certification Project Management Training/Certification Education and/or Experience: Bachelor’s Degree in Engineering Experience in the Medical Device / Pharmaceutical Industries: Yes 5+ years of experience in the following fields: Manufacturing New Product Transfers Product / Process Development Job Functions Experience in the following: Qualification / Validation (IQ/OQ/PQ) Test Method Validation / Gage R&R Packaging Validation Process Characterization / Design of Experiments (DOE) Manufacturing Line Design / Capacity Analysis Equipment / Tooling Design Equipment Installation / Preventive Maintenance Procedure Generation Root Cause Analysis / Investigation SOP / Manufacturing Procedures Generation & Change Control Product Financials & Supply Chain Structure Design OEE Integration, Vertical Start up and Zero-loss mindset #J-18808-Ljbffr
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