Sr. Manufacturing Engineer

Responsibilities

• Lead yield improvement initiatives across catheter manufacturing processes, including reflow, stringing, assembly, soldering, bonding, and packaging.
• Apply structured problem-solving methodologies (e.g., DMAIC, Root Cause Analysis, A3) to resolve manufacturing issues and improve process capability and robustness.
• Analyze manufacturing data to identify trends, process variation, and opportunities for cost, quality, and throughput improvements.
• Technical Leadership & Execution
• Serve as a technical subject matter expert in catheter manufacturing processes, materials, and equipment.
• Coordinate the design, procurement, build, and debugging of tooling, machinery, and test equipment.
• Support new product introductions (NPI), process scale up, and technology transfer from R&D to manufacturing.
• Work collaboratively with Quality, Process Development, R&D, Supply Chain, Operations, and Regulatory teams to ensure successful launches and sustained performance.
• Ensure manufacturing processes comply with FDA, ISO 13485, GMP, and Abbott quality system requirements.
• Provide technical guidance during investigations, process development, and continuous improvement activities.

• Bachelor’s degree in Mechanical, Chemical, Biomedical, or other relevant engineering discipline, or equivalent technical experience.
• Minimum 5 years of manufacturing engineering experience, with background in manufacturing or process development.

• Medical device manufacturing experience (required).

Previous experience supporting NPI, pilot builds, and ramp to production environments.