2nd-Shift Senior Manufacturing Engineer: Process Excellence

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

Job summary

Edwards Lifesciences in Salt Lake City, Utah, is seeking a Senior Manufacturing Engineer to lead complex manufacturing improvements in a highly regulated medical device setting. You will influence yield, capacity, and process capability while guiding cross-functional teams.

The role requires strong problem solving, statistics, and DOE skills, along with mentoring engineers and ensuring compliance with quality systems and FDA standards.

Qualifications

• Bachelor’s degree in Engineering or Science required with 4+ years of experience; Master’s with 3+ years; PhD with relevant experience.
• MBA or certification not required but helpful for leadership tasks.
• Experience in FDA-regulated medical device manufacturing is a plus.

Responsibilities

• Lead complex manufacturing improvement initiatives focused on yield stabilization, process capability, capacity expansion, cost reduction, and operational risk mitigation.
• Identify and implement opportunities to optimize manufacturing processes using structured problem solving, statistical analysis, Lean Manufacturing, and continuous improvement.
• Serve as a technical leader and SME for manufacturing processes, equipment, and technologies.
• Collaborate with cross-functional teams (Operations, Quality, Supply Chain, Maintenance) to improve performance and meet business objectives.
• Lead investigations and resolution of manufacturing, quality, and compliance issues including CAPAs, nonconformances, and audit observations.
• Apply data-driven decisions and DOE, SPC, and risk assessment to improve processes and implement corrective actions.
• Support regulatory inspections, internal audits, and compliance initiatives as a technical expert.
• Design and execute engineering studies, experiments, validations, and equipment qualifications.
• Develop protocols, analyze results, and deliver technical reports with implementation strategies.

Skills

Problem solving

Statistical analysis

Lean Manufacturing

Cross-functional collaboration

Project management

Structured problem solving

Education

Bachelor's degree in Engineering or Scientific field

Master's degree in Engineering or Scientific field

Ph.D. in Engineering or Scientific field

Tools

Microsoft Excel

Microsoft PowerPoint

Microsoft Project

Job description

Edwards Lifesciences in Salt Lake City, Utah, is seeking a Senior Manufacturing Engineer to lead complex manufacturing improvements in a highly regulated medical device setting. You will influence yield, capacity, and process capability while guiding cross-functional teams.

The role requires strong problem solving, statistics, and DOE skills, along with mentoring engineers and ensuring compliance with quality systems and FDA standards.