Sr Manufacturing Engineer- Medical Devices

We are seeking a Senior Manufacturing Engineer with deep, hands-onexpertisein medical device manufacturing to serve as a technical leader within our manufacturing organization. The ideal candidate will have 7-10 years of experience in medical device manufacturing engineering, with demonstrated,specificexpertisein catheter and balloon catheter manufacturing processes (including balloon forming, catheter shaft extrusion, tipping, bonding, and related assembly operations). This role acts as the senior technical authority on complex, high-risk manufacturing processes, driving process development, transfer, and continuous improvement independently and with minimal oversight, while mentoring junior engineers on catheter and balloon-specific manufacturing techniques.

This is an individual-contributor role with no formal direct reports.

• Catheter & Balloon Process Leadership:
  
  Serve as the senior subject-matter expert for catheter and balloon catheter manufacturing, including balloon forming/blow molding, compliance and burst testing, extrusion, tipping, skiving, marker band placement, shaft bonding, and RF/laser welding processes.

• Advanced Process Development & Optimization:
  
  Independently design, develop, andoptimizecomplex manufacturing processes for electro-mechanical devices and single-use disposable products, applying DOE, SPC, and lean methodologies to drive first-pass yield and throughput improvements.

• New Product Introduction (NPI) & Design Transfer:
  
  Lead manufacturing readiness activities for new catheter and balloon-based products, partnering with R&D to transfer designs from development into scalable,validated production.

• Technical Documentation & Design Controls:
  
  Author and approve manufacturing procedures, work instructions, SOPs, and process specifications; lead risk analysis, DHF contributions, and validation/verification protocols in compliance with FDA regulations and ISO 13485.

• Fixture, Tooling & Automation Design:
  
  Lead the design, development, and qualification of manufacturing fixtures, tooling, and semi/fully-automated equipment for catheter and balloon assembly, ensuring compliance with design controls.

• Process Validation Leadership:
  
  Own and lead IQ/OQ/PQ validation strategy and execution for new and existing catheter/balloon manufacturing processes and equipment.

• Root Cause Analysis & CAPA Leadership:
  
  Lead complex root cause investigations, drive corrective and preventive actions (CAPA), and champion continuous improvement initiatives across the production floor.

• ERP System Ownership:
  
  Utilize and oversee accuracy of the Epicor ERP system for Bills of Materials (BOMs), routing operations, work orders, inventory management, and production planning.

• Cross-Functional & Supplier Leadership:
  
  Act as the primary manufacturing engineering point of contact with Quality Assurance, Regulatory Affairs, R&D, and key suppliers on catheter/ballooncomponentand material qualification.

• Regulatory Compliance:
  
  Ensure all manufacturing processes comply withFDA 21 CFR Part 820, ISO 13485, ISO 14971, and other applicable medical device regulations.

• Mentoring & Technical Training:
  
  Mentor and train junior and mid-level manufacturing engineers and production personnel on catheter/balloon manufacturing techniques, process troubleshooting, and best practices, without formal supervisory authority.

• Production Support:
  
  Serve as the escalation point for complex production floor issues, troubleshooting and implementing solutions tomaintainproduction schedules and quality targets.

• Other duties and projects assigned.

• Education:
  
  Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, or related technical field required;
  
  Master'sdegree a plus.

• Experience:
  
  7-10 years of experience in medical device manufacturing engineering, including significant, hands-on experience with catheter and balloon catheter manufacturing (balloon forming/blow molding, extrusion, tipping, bonding, and related processes) —required. Proven experience with electro-mechanical device assembly and testing. Demonstrated experience with Epicor ERP or similar ERP software. Extensive experience in…