Class III Medical Device Production Associate

Is this you?

• Do you thrive on following standardized procedures that must be executed exactly—every time?
• Are you comfortable working under close supervision with frequent review to ensure world-class quality?
• Do you enjoy assembling intricate parts—often under a microscope—in a cleanroom environment?
• Can you keep meticulous records so every part remains fully traceable?

What the work involves

You’ll support a manufacturing cell building high-impact Class III devices: pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related assemblies. Expect a blend of assembly, basic repair, and testing activities performed according to specified, standardized procedures. Your contributions feed directly into life-sustaining products—and that’s why your output is continuously reviewed for accuracy and conformance.

Your responsibilities

• Carry out routine assembly, repair, and testing per SOPs for pacemakers, ICDs, and lead systems.
• Maintain up-to-date travelers and quality documentation to ensure complete traceability.
• Communicate issues and solutions clearly—both verbally and in writing—to all levels of manufacturing management.
• Interact positively with internal partners and with external visitors (including customer or community tours).
• Follow safety rules rigorously and use required protective devices for each operation.
• Participate in continuous improvement and quality initiatives aimed at achieving quality and profitability metrics.
• Support Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements, including FDA/GMP expectations.
• Collaborate with your Supervisor/Manager to set and monitor personal goals and cell-level performance metrics focused on ongoing quality improvement.

How you’ll succeed

• Apply a basic understanding of Lean manufacturing to daily tasks.
• Use electronic data collection tools and software systems to capture and manage production data.
• Read and follow written procedures; understand and act on verbal instructions.
• Prioritize by sequencing tasks based on precedence and importance to meet deadlines.
• Manipulate small parts safely and accurately; make time-critical decisions with minimal supervision when needed within defined processes.

Minimum education

High school diploma or equivalent required.

Relevant experience

• Quality inspection
• Cleanroom production
• Electromechanical and electronic assembly
• FDA/GMP compliance
• Medical device assembly
• Microscope-based assembly
• Manufacturing production