Quality Engineer I - Medical Device Manufacturing

Edwards Lifesciences Gruppe; Salt Lake City (UT); On-site; USD 80,000 - 105,000; Full time

Job summary

Edwards Lifesciences in Salt Lake City, UT, seeks a manufacturing quality engineer who will apply engineering principles to optimize medical device production processes. You will support design control activities, develop manufacturing documentation, and collaborate across teams to ensure product quality and regulatory compliance.

The role emphasizes LEAN methods, data-driven problem solving, and adherence to EHS and Quality guidelines.

Qualifications

• Bachelor's degree in engineering or a scientific field required.
• Strong problem-solving and analytical abilities.
• Excellent communication and interpersonal skills.
• Knowledge of statistical techniques and process controls is a plus.
• Experience with lab/industrial equipment is preferred.

Responsibilities

• Support design control activities related to manufacturing product and process.
• Develop documentation such as drawings, SOPs, routers, and pFMEA.
• Create basic training and production work instructions.
• Assist development of process controls and stability metrics.
• Support qualifications and validations (IQ, OQ, Software).
• Collaborate on root cause investigations and CAPA.

Skills

Problem solving

Analytical thinking

Organizational skills

Critical thinking

Communication skills

Interpersonal skills

Attention to detail

Education

Bachelor's degree in Engineering or Scientific field

Tools

MS Office Suite

MS Project

CAD

Job description

Edwards Lifesciences in Salt Lake City, UT, seeks a manufacturing quality engineer who will apply engineering principles to optimize medical device production processes. You will support design control activities, develop manufacturing documentation, and collaborate across teams to ensure product quality and regulatory compliance.

The role emphasizes LEAN methods, data-driven problem solving, and adherence to EHS and Quality guidelines.