Job Description

Step Into a Day of Precision

When you arrive, you review the day’s build plan and gown for the cleanroom. You’ll translate a Bill of Materials, product flow charts, work orders, check sheets, visual aids, production reports, and detailed assembly drawings into finished medical device subassemblies and products. You’ll move with focus—from kitting the right parts with a scanner and inventory software to in-process checks under a microscope—always aligned with approved manufacturing procedures and good manufacturing practices.

What You’ll Build and How

You’ll assemble plastic and metal components into regulated medical devices using an array of tools and fixtures. On any given day, that can include:

• Small manual and power hand tools, manual presses, assembly fixtures, calibrated instruments, and precision measurement equipment
• Microscopes, magnifiers, and test fixtures for micro-scale inspection and verification
• Specialized processes such as soldering, fabricating, crimping, mechanical assembly, sealing, ultrasonic welding, and bonding with adhesives including epoxy and RTV
• Kitting assemblies accurately with a parts list, scanner, and inventory software

Rhythm of the Shift

• Perform routine start-up and end-of-day equipment inspections and verifications
• Inspect your work throughout the assembly process and immediately escalate quality or operational issues to the appropriate lead
• Collaborate with Engineers and line leads to resolve issues and refine procedures for quality and efficiency
• Maintain a neat, organized, hazard-free work area; take part in safety programs, meetings, and trainings, and elevate any safety concerns
• Protect Clean Room integrity through proper attire and strict adherence to cleanroom practices and procedures

Quality, Compliance, and Documentation

• Meet quality, throughput, and GMP expectations to satisfy customers and Regulatory Affairs requirements
• Read and understand operating procedures for products you are trained to build
• Demonstrate unwavering attention to detail; report any nonconformances or deviations from approved process sheets immediately
• Participate in cross-functional continuous improvement initiatives
• Keep precise records for quality results, work-in-progress, test data, labor timecards, and special projects
• Adhere to safety rules, manufacturing procedures, company policies, and ISO, QSR, and FDA regulations

What You Bring

• At least 2 years of hands-on experience in a manufacturing environment
• Background in assembling, testing, and documenting mechanical and electrical devices
• Excellent interpersonal, verbal, and written communication skills
• Adaptability and a willingness to take on varied tasks in a dynamic environment
• Preferred: medical device manufacturing experience and familiarity with medical device regulatory procedures, lean manufacturing, and core manufacturing processes
• Strong hand-eye coordination and manual dexterity; comfortable with small-parts assembly under a microscope
• Proficiency with tweezers, torque drivers, magnifiers, and microscopes

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