JOB SUMMARY:

We are seeking a hands-on and detail-oriented Engineering with a strong background in CNC machinery, assembly processes, and regulated manufacturing—preferably within the medical device industry. This role provides technical support to engineers and scientists across a variety of manufacturing tasks, focusing on process improvement, equipment troubleshooting, and root cause analysis. The ideal candidate will be experienced in supporting complex production equipment, developing programs and fixtures, and working in a GMP-compliant environment.

• Provide technical support on the setup, operation, and troubleshooting of CNC machines, mechanical systems, and automated assembly equipment.
• Develop and validate CNC programs, custom fixturing, and process data to support efficient and accurate manufacturing.
• Assist engineers in drafting process documentation, SOPs, and technical reports in compliance with GMP and FDA regulations.
• Troubleshoot and repair mechanical, electrical, electronic, and software/hardware systems used in production and assembly.
• Perform root cause investigations of equipment failures or process deviations and implement corrective and preventive actions (CAPA).
• Coordinate and execute preventive maintenance, calibrations, and upgrades to ensure equipment performance and compliance.
• Support new product introductions (NPIs), equipment installations, validations (FAT/SAT), and technology transfers.
• Collaborate with engineering, operations, quality, vendors, and cross-functional teams to enhance equipment reliability and uptime.
• Drive equipment standardization and maintain accurate uptime metrics to reduce production downtime.
• Participate in site-wide continuous improvement initiatives targeting productivity, scrap reduction, and operational efficiency.