Cleanroom Technician

Electromechanical Assembly Technician – Medical Devices

This role focuses on assembling and testing medical devices in a regulated cleanroom environment. You will execute test protocols, assemble electronic and electromechanical components, and ensure all work complies with FDA regulations and Good Manufacturing Practices (GMPs). The position involves hands-on assembly using tools and automated equipment, as well as accurate documentation of all work performed.

• Execute test protocols and prepare detailed test reports in accordance with FDA requirements, internal procedures, and customer specifications.
• Set up the work area for assembly, ensuring all tools, materials, and equipment are properly prepared and organized.
• Fit and assemble parts using adhesives and hand tools such as screwdrivers to build medical device components and subassemblies.
• Utilize a 3D printer and spinner to fabricate parts and components used in medical devices.
• Follow all Good Manufacturing Practices (GMPs) and applicable FDA regulations throughout the assembly and testing process.
• Bond and solder parts together using automatic equipment to create reliable electrical and mechanical connections.
• Assemble and handle printed circuit boards (PCBs) and electronic components in accordance with established standards.
• Review work orders thoroughly to understand the product or component to be assembled and the required specifications.
• Complete all required documentation for each work order accurately and in a timely manner, including production, testing, and quality records.
• Maintain a clean, organized, and compliant cleanroom work area, adhering to all environmental and contamination control procedures.
• Collaborate with a small team of assemblers to meet production goals and ensure consistent product quality.
• Adhere to all company policies, safety procedures, and regulatory requirements related to medical device manufacturing.

• At least 3 years of experience in electromechanical assembly or electronic assembly.
• Hands-on experience with electronic assembly and PCB (printed circuit board) assembly.
• Proficiency with soldering, including working with automatic soldering equipment.
• Ability to execute test protocols and document test results accurately.
• Experience working with medical devices or in a regulated manufacturing environment.
• Familiarity with FDA regulations and Good Manufacturing Practices (GMPs).
• Ability to read, understand, and follow work orders and technical instructions.
• Strong attention to detail and commitment to producing high-quality work.
• Comfort working in a cleanroom environment with strict cleanliness and contamination control standards.
• Basic proficiency with hand tools such as screwdrivers and other assembly tools.

• IPC-610 certification is preferred.
• Prior medical device manufacturing experience is preferred.
• Experience as a cleanroom technician or in other controlled environments is beneficial.
• Familiarity with electronic assembly standards and best practices.
• Experience using 3D printers and related equipment for component fabrication.
• Ability to collaborate effectively in a small team environment.
• Strong documentation and record-keeping skills for regulated industries.

You will join a dynamic, collaborative environment focused on building innovative medical devices that directly impact patients' lives. The facility supports a wide range of projects for organizations of all sizes, offering exposure to cutting-edge technologies and products. You will work in a modern, shared innovation space that encourages collaboration, knowledge sharing, and continuous learning, while benefiting from a stable daytime schedule that supports work–life balance.