Technical Lead, NPI Manufacturing Engineer

About You 

• Provide leadership and guidance to the Manufacturing Engineering team (ME) during NPI New Product Introduction through sustaining. 

• Manages ME processes, improvements, and execution of time based deliverables 

• Implement lean manufacturing principles, drive continuous improvement initiatives, and utilize data analytics to streamline ME operations, increase productivity, and reduce cost in processes. 

• Creates and improves processes and procedures for ME and related areas. 

• Excellent theoretical, analytical, and practical skills; appropriately applied to resolving manufacturing issues. 

• Develops and supports effective product field returns strategy and procedures 

• Escalates and resolves design, manufacturability, quality, and supply chain issues 

• Responsible for setting up DMR/DHR/LHR management for a complex system 

• Creates workflow process diagrams, detailed manufacturing and shipping work instructions, procedures, checklists, travelers, product and equipment maintenance plans 

• Develops floor and line layout proposals for build capacity, quality, time optimization and effective inventory management 

• Participates in BOM management, technical specification reviews, new part requisitions 

• Leads process failure mode and analysis (PFMEA) activities 

• Develops and validates critical tests used in production workflow to minimize risk 

• Responsible for the activities of validation and qualification of manufacturing equipment and processes utilizing standard qualification approaches (IQ/OQ/PQ) 

• Manages development and delivery of completed validation plans, studies, and reports 

• Provides feedback for product and process DFM improvements to R&D to ensure optimal manufacturability and serviceability 

• Provides technical support in analyzing and/or performing investigation for discrepant production components, assemblies, and field returns 

• Assists with assembly, testing, and troubleshooting of new products 

• Provides leadership, training, and technical support to production technicians 

• Implements fixtures to aid in production, maintenance, and service 

• Support Good Manufacturing Practices and quality management system in accordance with FDA regulatory and ISO 13485 requirements. 
• Other related duties. 

Qualifications 

• Minimum a four-year degree (Bachelor’s) in industrial or mechanical engineering or an equivalent combination of education and experience in medical devices with QSR/FDA ISO 13485:2016 or in a highly regulated manufacturing environment 

• Need a minimum of 5 years of experience in manufacturing engineering of complex electromechanical devices and medical device 

• Must be able to read and understand assembly drawings, BOMs, workflow diagrams, MPIs,  and read basic schematics 

• Good written and verbal communication skills with all levels of employees, suppliers, and internal customers 

• Demonstrates ability to grow in career 

 

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