Manufacturing Process Engineer

Manufacturing Process Engineer

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.

• 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.
• Eliminate safety and quality risks in the process through the delivery of robust engineering solutions.
• Support machinery maintenance system activities for equipment and fixtures.
• Manage costs through the delivery of scrap, reprocessing, and consumable reduction projects.
• Modify and develop tools, fixtures, gauges, and special equipment for manufacturing operations in conjunction with Toolroom technicians and outside vendors.
• Develop stable and capable manufacturing processes through a structured process development approach.
• Perform scrap and cost analysis based on evaluation of manufacturing processes 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 process development to highlight potential failure modes and evaluate identified risks using PFMEA.
• Prepare all relevant manufacturing specifications.
• Ensure competency in validation requirements for new consumables/materials and process changes.
• Update and maintain manufacturing specifications for process steps.
• Ensure timely closure of quality actions such as Audit Actions, NCRs, and CAPAs.
• Ensure all process development and validation activities are managed in accordance with the Quality Management System.
• Utilize personal computer software including Windows, word processing, project planning, presentation, and email applications.
• Implement laboratory controls in the polymer lab based on internal regulatory compliance standards.
• Serve as Materials R&D SME/DRI for material supplier validations by analyzing supplier data, authoring protocols, coordinating test specimens, and updating material specifications.
• Direct Manufacturing process improvement activities to ensure overall business objectives are achieved.

• Manufacturing Process Development
• Manufacturing Engineering
• Manufacturing Operations
• Process Validation
• IQ/OQ/PQ
• PFMEA
• CAPA
• Client
• QMS
• Risk Assessment
• Tooling & Fixture Development
• Manufacturing Tools and Gauges
• Scrap Reduction
• Cost Optimization
• Continuous Improvement
• Medical Device Manufacturing
• Supplier Validation
• Material Validation
• Root Cause Analysis
• Manufacturing Specifications
• Process Improvement
• Quality and Regulatory Compliance
• Polymer Materials / Laboratory Controls

• Bachelor's degree in Mechanical Engineering or equivalent.
• 5–10 years of experience in manufacturing process and operations.
• Experience in the medical device industry is required.
• Strong experience in manufacturing process development and process improvement.
• Experience with process validation, including IQ/OQ/PQ.
• Experience with PFMEA, CAPA, Client, QMS, and risk assessment.
• Experience developing tooling, fixtures, gauges, and special manufacturing equipment.
• Experience with supplier and material validations.
• Strong analytical, problem-solving, communication, and cross-functional collaboration skills.