Manufacturing Engineer

Job Description

Primary Function of Position

This role manages advanced manufacturing engineering projects, process validation and optimization, and compliance with medical device regulations for production scale-up and improvement.

Essential Job Duties

• Lead process improvement and optimization projects for manufacturing lines.
• Design and validate manufacturing processes and equipment per regulatory standards.
• Analyze production data to identify and address performance gaps or inefficiencies.
• Develop and execute equipment validations, IQ/OQ/PQ protocols.
• Investigate and resolve process and equipment failures.
• Manage change control and update technical documentation (SOPs, WI, BOMs).
• Support new product introduction and transfer to manufacturing.
• Mentor and train junior engineers and production staff.
• Participate in regulatory audits and ensure compliance with FDA, ISO 13485.
• Drive continuous improvement and cost reduction initiatives.