Cleanroom Electromechanical Assembler -- Pacemakers & ICDs

Job Description

Job Description

Build with purpose

Join a team where every component you assemble can change a life. In this cleanroom-based role, you’ll help produce high-quality pacemakers, ICDs, leads, and related device assemblies. You’ll execute routine tasks using standardized instructions while operating under close supervision; your work will be reviewed continuously to ensure absolute compliance and quality.

• Deliver precise assembly, repair, and testing of implantable cardiac devices and subassemblies.
• Safeguard traceability and compliance by keeping travelers and quality records accurate and current.
• Advance continuous improvement to enhance processes and achieve quality and profitability goals.
• Model safety by following guidelines and using the right protective devices for every step.

• Perform routine work per specified/standardized procedures within a manufacturing cell.
• Document activities meticulously so all parts and processes remain traceable.
• Communicate clearly—both verbally and in writing—sharing ideas, issues, and solutions with manufacturing management.
• Interact positively with internal customers and with external visitors (including tour groups).
• Partner with your Manufacturing Supervisor/Manager to set personal goals and track cell performance metrics that drive continuous quality improvement.
• Support divisional initiatives aligned to QMS, EMS, and other applicable regulations, including FDA/GMP compliance.

• Basic Lean manufacturing concepts and how to apply them on the line.
• Reading, comprehending, and following written procedures; understanding and executing verbal instructions.
• Using electronic data collection systems and software to record and manage production information.
• Prioritizing and sequencing tasks based on precedence and importance to meet schedule requirements.
• Handling small parts precisely; making sound judgments with minimal supervision when appropriate within defined processes.

High school diploma or equivalent.

• Quality inspection experience
• Cleanroom manufacturing
• Electromechanical assembly
• Electronic assembly
• FDA/GMP compliance
• Medical device assembly
• Microscope-assisted assembly
• Manufacturing production