Manufacturing Engineering Technician

Manufacturing Engineering Technician

As a Manufacturing Engineering Technician, you will support manufacturing engineers and programmers in designing, developing, and improving manufacturing processes, tools, and equipment. This role is hands-on and focused on ensuring efficient, safe, and high-quality production operations. This full-time onsite position is available to start immediately and is a great opportunity in the exciting medical device industry.

Location: Onsite - Draper, UT

Schedule: Monday-Friday

Your responsibilities:

- Follow documented procedures, work instructions, and cleanroom protocols to manufacture high-quality medical device components.

- Perform first-part inspections and prove-outs on CNC machines, including setup and changeovers.

- Produce prototypes and support pilot builds for new product development.

- Act as the first responder to equipment malfunctions or quality issues; perform initial troubleshooting and escalate to appropriate personnel as needed.

- Communicate effectively with engineering, quality, and production teams to resolve issues promptly.

- Adhere to all quality requirements as defined by the Quality Management System (QMS), including FDA and ISO 13485 standards.

- Support documentation and traceability for Device History Records (DHRs) and ensure compliance with Good Manufacturing Practices (GMP).

- Assist in the setup, validation, and optimization of manufacturing processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

- Monitor production lines for process inefficiencies and recommend improvements to enhance throughput and reduce waste.

- Implement lean manufacturing principles and contribute to continuous improvement initiatives.

- Maintain, calibrate, and troubleshoot manufacturing equipment and tooling to ensure consistent and reliable performance.

- Collaborate in the design, testing, and implementation of jigs, fixtures, and automation solutions to improve process capability.

- Create, revise, and maintain work instructions, standard operating procedures (SOPs), and process documentation.

- Accurately record test results, equipment performance data, and process changes to support audits and regulatory inspections.

- Maintain documentation related to quality improvements and engineering change orders.

- Work closely with manufacturing engineers, R&D, quality assurance, and production teams to support daily operations and strategic initiatives.

- Support new product introductions (NPI) and design transfer activities from development to production.

- Train operators and technicians on new equipment, processes, and quality standards.

- Follow all safety protocols and environmental regulations, including cleanroom and contamination control procedures.

- Participate in safety audits, risk assessments, and hazard analyses to ensure a safe working environment.

- Perform other job-related duties as assigned.

Requirements:

Specific training courses in this field:

- Machining certificate or trade school (Preferred)

- Experience programming CNC equipment (Preferred)

- Experience with ERP systems (Preferred)

Experience specific to this position:

- 5+ years experience

- Use of inspection equipment, e.g. calipers, microscope, optical measurement

- Operation of manual and coordinated measuring machines

- Strong troubleshooting skills for process and equipment issues

- Set Up and Operation of 5 axis CNC equipment

- Experience with manual mill and lathe