Electro mechanical Assembler/Medical Device

This role offers a dynamic mix of precision micro-assembly and capital equipment builds. Because it splits time evenly between a cleanroom environment and electromechanical hardware, it requires both fine-motor dexterity and solid mechanical/electrical aptitude.

Core Responsibilities

• Cleanroom Micro-Assembly (50%): Build optofluidic micro-cartridges inside a controlled cleanroom setting, utilizing microscopes, fine tools, and precision component-handling techniques while following strict gowning protocols.
• Capital Equipment Assembly (50%): Build, wire, and integrate electromechanical subassemblies and full systems, including lasers, optics, cameras, PCBs, brackets, and structural framing.
• Engineering & Process Support: Partner with engineering teams to run IQ/OQ/PQ validations, build prototype iterations, test new assembly fixtures, and provide practical feedback on workflow improvements.
• Documentation & Maintenance: Help draft or update Standard Operating Procedures (SOPs) and work instructions, log test data, and carry out routine preventive maintenance on production tools.
• Operations & Quality: Assist with incoming component inspections, material handling, receiving, and routine inventory counts as needed in a nimble manufacturing setup.

Key Qualifications & Skills

• Technical Background: Proven hands-on assembly experience in medical device, IVD, or complex electromechanical hardware environments.
• Cleanroom & Precision Capabilities: Full comfort working under microscope magnification and adhering to cleanroom gowning and contamination-control standards.
• Blueprint Reading: Ability to interpret schematics, engineering drawings, wiring diagrams, and detailed manufacturing work instructions.
• Troubleshooting: Strong practical problem-solving skills to diagnose hardware fit issues or assembly anomalies.
• Preferred Experience: ~5 years in an FDA-regulated/cGMP environment, exposure to process validation protocols (IQ/OQ/PQ), basic SolidWorks/CAD familiarity, or light shop/fabrication skills.

Work Environment & Expectations

• High balance of active, bench-level assembly work with low desk-bound time.
• High demand for flexibility, jumping between fine optofluidic work and heavy hardware integration based on daily production priorities.

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