Medical Device Manufacturing Engineer: Process Optimization

ATR International; Irvine (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

ATR International is seeking a Manufacturing Engineer / Process Engineer (Specialist) to lead critical projects in a medical device production setting, driving cost, safety, service continuity, and quality improvements.

You will design and optimize manufacturing processes, validate equipment, and mentor junior staff while partnering with design teams to ensure manufacturability and compliance with regulatory standards.

Qualifications

• Bachelor’s degree in Engineering or related technical discipline with relevant experience.
• Advanced degree preferred with minimum years of relevant experience.
• Medical device manufacturing experience and project leadership skills.

Responsibilities

• Lead end-to-end projects focused on cost, safety, continuity, and quality.
• Design and optimize manufacturing processes and layouts.
• Oversee equipment selection, installation, qualification, and validation.
• Drive Lean Six Sigma initiatives and continuous improvement.
• Ensure manufacturability of designs and regulatory compliance.
• Communicate with senior stakeholders and mentor junior engineers.

Skills

Project management

Lean Six Sigma

Equipment qualification

Process validation

Design for manufacturability

Quality & compliance

Vendor interaction

Mentorship

Education

Bachelor's degree in Engineering

Master's degree (preferred)

Job description

ATR International is seeking a Manufacturing Engineer / Process Engineer (Specialist) to lead critical projects in a medical device production setting, driving cost, safety, service continuity, and quality improvements.

You will design and optimize manufacturing processes, validate equipment, and mentor junior staff while partnering with design teams to ensure manufacturability and compliance with regulatory standards.