Process Development Engineer

About This Role

This role supports manufacturing process development and validation for Class III medical devices, focusing on process optimization, validation execution, and GMP-compliant documentation.

Responsibilities

• Lead process development, optimization, and validation activities for Class III devices
• Execute IQ/OQ/PQ, TMV, and risk management documentation
• Develop and validate manufacturing processes, test methods, and equipment
• Implement process improvements and automation solutions to reduce manual operations
• Collaborate with R&D, QA, and Production to transfer processes into manufacturing
• Ensure full compliance with GMP and ISO 13485 requirements

Requirements

• 5+ years of process development / manufacturing engineering experience in the medical device industry
• Hands-on experience with Class III medical devices
• Strong expertise in process validation (IQ, OQ, PQ, PPQ, TMV/IMV)
• GMP and ISO 13485 compliance and documentation experience
• Ability to independently lead process development and validation activities
• Experience developing or validating test methods, equipment, or fixtures

Qualifications

• 5+ years of process development / manufacturing engineering experience in the medical device industry