Senior Manufacturing Engineer, 2nd Shift

RiseMe; Draper (UT); On-site; USD 110,000 - 150,000; Full time

Job summary

Edwards Lifesciences is seeking a Senior Manufacturing Engineer to lead process improvements in a regulated medical device production environment. You will drive yield, capacity, and cost reduction initiatives, guiding cross-functional teams across Operations, Quality, and Supply Chain.

The role requires strong problem solving, DOE/SPC proficiency, and experience with CAPA systems within FDA-regulated manufacturing. You will mentor staff and support technology transfers and validation activities.

Qualifications

• Bachelor's degree in Engineering or Science with 4+ years experience, or
• Master's degree with 3+ years, or PhD with applicable experience.
• Experience in a regulated medical device environment is preferred.

Responsibilities

• Lead complex manufacturing improvement initiatives for yield, capacity, and cost reduction.
• Collaborate with Operations, Quality, and Supply Chain to meet objectives.
• Guide investigations for CAPAs, nonconformances, and audit findings.
• Apply DOE, SPC, and risk-based methods to drive process validation and qualification.
• Mentor engineers and technicians in problem-solving and process control.

Skills

Lean Six Sigma

Statistical analysis

Cross-functional collaboration

Problem solving

Regulatory awareness

Education

Bachelor's Degree in Engineering or Science

Master's Degree or PhD preferred

Tools

Excel

Project

CAPA systems

Job description

Edwards Lifesciences is seeking a Senior Manufacturing Engineer to lead process improvements in a regulated medical device production environment. You will drive yield, capacity, and cost reduction initiatives, guiding cross-functional teams across Operations, Quality, and Supply Chain.

The role requires strong problem solving, DOE/SPC proficiency, and experience with CAPA systems within FDA-regulated manufacturing. You will mentor staff and support technology transfers and validation activities.