Senior Manufacturing Engineer - Medical Devices

Edwards Lifesciences; Draper (UT); On-site; USD 110,000 - 170,000; Full time

Job summary

Edwards Lifesciences in Utah seeks a Senior Manufacturing Engineer to support Advanced Catheter manufacturing operations, drive sustaining, production line support, and yield improvement initiatives. You will lead complex manufacturing improvement initiatives, collaborate with cross-functional teams, apply DOE, SPC, and risk-based methods, and mentor engineers and technicians.

The role supports regulatory inspections, new product transfers, and ensures safety, quality, and operational readiness

Qualifications

• Bachelor's degree with 4+ years of engineering or scientific experience
• Master's or PhD with relevant experience
• Preferred familiarity with FDA-regulated medical device manufacturing

Responsibilities

• Lead manufacturing improvement initiatives focused on yield stabilization, process capability, capacity expansion, cost reduction, and risk mitigation.
• Identify opportunities to optimize processes using structured problem solving, Lean, and data-driven methods.
• Serve as technical leader for manufacturing processes, equipment, and related technologies.
• Collaborate across Operations, Quality, Supply Chain, Maintenance and other teams to improve performance.
• Lead investigations and resolutions of complex manufacturing, quality, and compliance issues including CAPAs and audit observations.
• Develop protocols and conduct analyses to drive corrective and preventive actions.

Skills

Manufacturing leadership

Six Sigma

DOE

SPC

Cross-functional collaboration

Mentoring

Education

Bachelor’s degree in Engineering or Scientific field

Master’s degree or equivalent in Engineering or Scientific field

Ph.D. or equivalent in Engineering or Scientific field

Tools

Excel

PowerPoint

Microsoft Project

Job description

Edwards Lifesciences in Utah seeks a Senior Manufacturing Engineer to support Advanced Catheter manufacturing operations, drive sustaining, production line support, and yield improvement initiatives. You will lead complex manufacturing improvement initiatives, collaborate with cross-functional teams, apply DOE, SPC, and risk-based methods, and mentor engineers and technicians.

The role supports regulatory inspections, new product transfers, and ensures safety, quality, and operational readiness