Assembly Tech IV

Job Title: Assembly Technician IV Department: Operations Reports To: Production Supervisor FLSA Status: Non-Exempt

Job Summary and Objectives:

The Assembly Technician IV performs advanced assembly and testing of complex FDA Class II and III medical devices; including implantable medical devices in a Class 7 cleanroom environment. This position requires proficiency across multiple products and manufacturing processes, including mechanical, electrical, pneumatic, and fluidic assemblies and processes.

Working with minimal supervision, the Assembly Technician IV serves as a technical resource for production personnel, troubleshoots complex assembly and test issues, and provides hands-on training and mentoring to Assembly Technicians I, II, and III. The position partners with Production, Engineering, and Quality to resolve manufacturing problems, support new product introductions, and improve quality and production efficiency while following approved procedures and maintaining required good documentation practices (GDP).

Essential Duties and Responsibilities

• Perform the most complex assembly and final-build operations within assigned product lines, using approved drawings, schematics, work instructions, fixtures, and equipment.
• Demonstrate proficiency across multiple assembly processes and provide technical support to Assembly Technicians I, II, and III.
• Accurately perform calculations and properly choose proper pass/fail decisions where required based on documented specifications.
• Perform precision assembly in designated cleanroom environments while following approved gowning, hygiene, cleaning, material-transfer, and contamination-control procedures.
• Serve as a resource for cleanroom practices, identify potential contamination risks, and promptly escalate departures from established requirements.
• Troubleshoot complex mechanical, electrical, pneumatic, and fluidic assembly problems using approved diagnostic methods and test equipment.
• Perform authorized rework and repair in accordance with approved instructions and applicable training.
• Serve as a designated trainer for assigned processes; demonstrate proper techniques, assess trainee performance, and document training in accordance with Company procedures.
• Assist production management with daily work coordination, technical questions, and identification of material, equipment, or process constraints.
• Support Engineering and Quality with pilot builds, production transfers, process validation activities, and investigation of recurring defects.
• Recommend improvements to work instructions, tooling, fixtures, workstation layout, and assembly methods; implement changes only after required approval.
• Complete accurate production, inspection, test, and traceability records, and review assigned records for completeness when authorized.
• Identify and escalate nonconforming product, process deviations, and equipment concerns in accordance with Company procedures.

Additional Required Skills/Abilities

• Advanced ability to interpret assembly drawings, electrical schematics, wire-run diagrams, bills of materials, and complex work instructions.
• Experience with building implantable medical devices beneficial.
• Demonstrated ability to diagnose assembly and test failures and communicate findings to Production leadership, Engineering, and Quality.
• Proficiency in cleanroom gowning, contamination prevention, controlled material handling, and cleaning practices.
• Ability to train others effectively and reinforce consistent adherence to approved methods.
• Ability to recognize when an issue requires escalation or additional authorization.
• Ability to work under a microscope with very small, fragile components.
• Ability to perform soldering tasks.
• Strong mechanical and electrical aptitude abilities, including troubleshooting assemblies when required.
• Use of manual and electronic torque tools, and other wrenches and tools.
• Use of wire cutters, crimping tools, and soldering.
• PCBA handling, integration, and connectivity with proper ESD practices.
• Assembly of pneumatic and fluidic systems including pumps, tubing, and various interconnects.
• Use of inspection tools such as vernier calipers and digital height gauges.
• Use of part cleaning technologies such as ultrasonic cleaning.
• Ability to communicate effectively through oral and written communications.
• Ability to work with others collaboratively.
• Attention to detail to understand and meet the requirements.
• Strong organizational skills.
• Demonstrated problem solving ability in a cross functional environment.
• Take responsibility for task and time management.