Senior Manufacturing Engineer, Medical Devices

Edwards; Salt Lake City (UT); On-site; USD 90,000 - 130,000; Full time

Job summary

Edwards Lifesciences in Salt Lake City seeks a Senior Manufacturing Engineer to sustain and improve Advanced Catheter operations. You will lead yield initiatives, mentor teams, and collaborate across Operations, Quality, and Supply Chain to resolve complex manufacturing challenges.

The role emphasizes data-driven methods, DOE/ SPC, and rigorous process validation to meet safety and regulatory standards in a fast-paced environment.

Qualifications

• Bachelor's, Master's, or PhD in Engineering or Scientific field with relevant experience.
• Experience applying DOE, SPC, and process validation.
• FDA regulations and quality system knowledge preferred.

Responsibilities

• Lead manufacturing improvement initiatives focused on yield, capability, and cost.
• Collaborate with cross-functional teams to optimize processes.
• Lead investigations and CAPAs, nonconformances, and audits.
• Apply data-driven decision making to identify root causes and corrective actions.
• Develop protocols, run experiments, and document results.
• Support new product transfers and equipment integration.

Skills

Lean Manufacturing

Structured problem solving

Project management

Data analysis

Regulatory knowledge

Education

Bachelor's Degree in Engineering or Science

Master's Degree in Engineering or Science

Ph.D. in Engineering or Science

Tools

DOE

SPC

Quality systems knowledge

Microsoft Office Suite

Job description

Edwards Lifesciences in Salt Lake City seeks a Senior Manufacturing Engineer to sustain and improve Advanced Catheter operations. You will lead yield initiatives, mentor teams, and collaborate across Operations, Quality, and Supply Chain to resolve complex manufacturing challenges.

The role emphasizes data-driven methods, DOE/ SPC, and rigorous process validation to meet safety and regulatory standards in a fast-paced environment.