Senior Manufacturing Engineer

Position Overview

Our client is seeking a Senior Manufacturing Engineer to support the development, transfer, and optimization of manufacturing processes for innovative medical device products. This role partners closely with Engineering, Quality, Operations, and Supply Chain teams to ensure products are manufactured efficiently, compliantly, and to the highest quality standards.This is an excellent opportunity for an experienced engineer with expertise in New Product Introduction (NPI), process development, Lean manufacturing, and continuous improvement within a regulated medical device environment.

Responsibilities

• Lead the development, implementation, and optimization of manufacturing processes, equipment, and tooling
• Support New Product Introduction (NPI) activities, including process development, validation, and transfer into production
• Develop and maintain manufacturing documentation, including work instructions, process flows, routings, and PFMEAs
• Drive process verification and validation activities in compliance with FDA and ISO 13485 requirements
• Partner with Design Engineering to ensure Design for Manufacturability (DFM) principles are incorporated into product development
• Lead Lean Manufacturing and continuous improvement initiatives focused on quality, efficiency, throughput, and cost reduction
• Analyze manufacturing data and metrics to identify opportunities for process improvements
• Support quality systems activities including CAPAs, nonconformance investigations, complaint reviews, and audit readiness
• Collaborate with suppliers and contract manufacturers to resolve technical and quality-related issues
• Conduct capacity planning, labor analysis, line balancing, and workflow optimization
• Support facility expansion, equipment installation, and manufacturing layout projects

Qualifications

Required

• Bachelor’s degree in Manufacturing Engineering, Industrial Engineering, Mechanical Engineering, or related technical field
• 8+ years of manufacturing engineering experience
• 3+ years of experience in a medical device manufacturing environment regulated by FDA QSR and ISO 13485
• Experience supporting NPI and product transfers into manufacturing
• Strong knowledge of process validation, test method validation, and risk management tools such as PFMEA
• Experience working with complex electromechanical products
• Strong problem-solving, root cause analysis, and project management skills

Preferred

• Lean Manufacturing and/or Six Sigma certification
• Experience with ERP and PLM systems
• Proficiency with statistical analysis tools such as Minitab
• Experience working with suppliers and contract manufacturers

Why Join?

• Opportunity to contribute to life-changing medical technologies
• Highly visible role supporting both product development and manufacturing operations
• Collaborative, cross-functional work environment
• Ability to lead meaningful process improvement initiatives
• Stable, growing organization focused on innovation and quality