Job summary :
Manufacturing Process Engineer with 5-10 years of experience in manufacturing engineering and operations within the medical device industry. Responsible for driving process improvements, supporting manufacturing operations, and delivering engineering solutions that improve quality, safety, productivity, and cost efficiency. Experience in process development, validation (IQ/OQ/PQ), PFMEA, CAPA/Client management, tooling and fixture development, material validations, and QMS compliance. Proven ability to optimize manufacturing processes, reduce waste, support supplier validations, and ensure regulatory compliance in a highly regulated environment.
Responsibilities :
• Mechanical Engineering with experience in manufacturing process and operations.
• Support attainment of key business metrics through the provision of engineering support for value stream processes.
• Elimination of safety and quality risks in the process through the delivery of robust engineering solutions.
• Machinery maintenance system support activities for equipment and fixtures.
• Manage costs through the delivery of scrap, reprocessing and consumable reduction projects.
• Modify & Develop tools, fixtures, gauges and special equipment for manufacturing operations in conjunction with Toolroom technicians and outside vendors.
• Develop stable and capable manufacturing process through a structured process development approach.
• Perform scrap and cost analysis based on evaluation of manufacturing process for minimizing waste and maximizing production.
• Ensure all process development, validation (IQ, OQ, PQ) etc. is managed in accordance with the Quality management system (QMS).
• Perform Risk Assessment on the process of development to highlight potential failure modes and evaluate identified risks using PFMEA.
• Preparation of all relevant manufacturing specifications.
• Competent in validation requirements for new consumables/materials and process changes.
• Update and maintenance of manufacturing specifications for process steps.
• Ensure timely closure of quality actions such as Audit Actions, Client's, CAPA's.
• Ensure all process development, validation, etc, is managed in accordance with the Quality management system.
• Personal computer software – Windows: word processing, project planning, presentation, e-mail.
• Implemented laboratory controls in the polymer lab based on internal regulatory compliance standards.
• Materials R&D SME/DRI for material supplier validations: analyzed supplier data, authored protocols and coordinated test specimens, and updated material specifications
Top Skills:
Manufacturing Process Development | Process Validation (IQ/OQ/PQ) | PFMEA | CAPA | Client | QMS | Risk Assessment | Manufacturing Operations | Tooling & Fixture Development | Scrap Reduction | Cost Optimization | Continuous Improvement | Medical Device Manufacturing | Supplier Validation | Root Cause Analysis
Additional Information:
• Bachelor in Mechanical Engineering or equivalent with 5-10 year's experience in manufacturing process and operations.
• Responsible for directing Manufacturing process improvement activities to ensure that the overall business objectives are achieved.
• Medical domain experience