Senior Manufacturing Engineer

About the role

The Senior Manufacturing Engineer will join the New Product Introduction (NPI) Operations team to drive rapid performance improvements for newly launched catheter products. This individual contributor role also leads cross‑functional projects that span Operations, Supply Chain, Quality, and Development.

Key responsibilities

• Lead yield improvement initiatives across catheter manufacturing steps such as reflow, stringing, assembly, soldering, bonding, and packaging.
• Apply structured problem‑solving methods (DMAIC, Root Cause Analysis, A3) to resolve issues and enhance process capability.
• Analyze production data to identify trends, variation, and opportunities for cost, quality, and throughput gains.
• Serve as technical subject‑matter expert for catheter processes, materials, and equipment.
• Coordinate design, procurement, build, and debugging of tooling, machinery, and test equipment for NPI and scale‑up.
• Collaborate with Quality, R&D, Supply Chain, Operations, and Regulatory teams to ensure compliant and successful product launches.
• Mentor junior engineers and technicians, providing guidance during investigations and continuous‑improvement activities.

Required profile

• Bachelor’s degree in Mechanical, Chemical, Biomedical, or related engineering discipline, or equivalent experience.
• Minimum 5 years of manufacturing engineering experience, preferably in medical‑device environments.
• Proven experience supporting NPI, pilot builds, and ramp‑up to full production.
• Strong analytical, problem‑solving, and project‑management capabilities.
• Demonstrated leadership ability to motivate peers and drive change.

Required skills

• DMAIC methodology
• Root Cause Analysis
• A3 problem‑solving
• Reflow, stringing, assembly, soldering, bonding, packaging processes
• FDA, ISO 13485, GMP compliance knowledge