Process Engineer Development Improvement

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

Process Engineer Development Improvement

• Contract

SCT resources have a broad range of skills in different technologies. The large skill-set has been made possible by a conscious focus on strengthening our skills base. Every person selected for our team brings something new, something that adds to our offerings. We learn continuously, both on the job and through formal training programs.

World wide office: Canada - USA - Australia - UK - South Africa - New Zealand - Ireland - Japan

Job Description

Extensive experience in Product Development, Sustaining, Compliance to FDA regulations, Quality, Process and Manufacturing Engineering of medical equipment/devices

Responsible for the design and specification of tooling and equipment, validation & verification, design and development of processes.

Develop best practice in executing process development, scale-up, validation and manufacture troubleshooting.

Develop contractor site of manufacture and packaging supplier. Significantly improved the QA system and technical transfer procedure.

Provide cost improvement project and process optimization.

Prefer certified as Six Sigma Green Belt.

Prefer experience of CAPA investigation.

Experience on of Class I and II medical devices. Experience on implementing structure following cGMPs for medical devices using ISO 13485.