Medical Device Process Engineer: Development and Validation

System Canada; United States; On-site; USD 80,000 - 100,000; Full time

Job summary

A leading engineering company is seeking a Process Engineer to enhance process development and compliance in manufacturing medical devices. The ideal candidate will have extensive experience in process optimization and quality assurance, particularly in FDA-regulated environments. Responsibilities include design specifications and significant improvements in QA systems. Candidates with Six Sigma Green Belt certification are preferred. This role is located in the United States.

Qualifications

• Extensive experience in Product Development and Manufacturing Engineering.
• Experience with Class I and II medical devices.
• Prefer certified as Six Sigma Green Belt.

Responsibilities

• Responsible for the design and specification of tooling and equipment.
• Develop best practices in process development and validation.
• Significantly improve the QA system and technical transfer procedure.

Skills

Process improvement

FDA compliance

Quality Assurance

Process development

Manufacturing engineering

Six Sigma Green Belt

CAPA investigation

Job description

A leading engineering company is seeking a Process Engineer to enhance process development and compliance in manufacturing medical devices. The ideal candidate will have extensive experience in process optimization and quality assurance, particularly in FDA-regulated environments. Responsibilities include design specifications and significant improvements in QA systems. Candidates with Six Sigma Green Belt certification are preferred. This role is located in the United States.