Medical Device Machine Operator

Cynet Systems•Scarborough, ME

About The Position

This position is responsible for producing high-quality medical devices within a manufacturing cell. Under close supervision, the operator performs routine assembly, repair, and testing operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device assemblies, following specified or standardized procedures. The role requires accurate documentation and traceability, adherence to safety and regulatory requirements, and participation in quality and continuous-improvement initiatives.

Requirements

Ability to read, comprehend, and follow written procedures and understand and follow verbal instructions.
Understanding of and ability to use electronic data collection systems and computer software packages.
Ability to prioritize work by sequencing and timing different jobs based on precedence and importance.
Ability to make critical decisions and judgments with minimal supervision.
High school degree or equivalent required.
Ability to handle and maneuver small components and parts.

Responsibilities

Perform assembly, repair, and test operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device assemblies under close supervision.
Complete routine assignments according to specified or standardized procedures.
Keep job documentation for cell operations and functions accurate and up to date.
Communicate ideas, problems, and solutions clearly, both orally and in writing, to all levels of manufacturing management.
Maintain a positive attitude when interacting with internal and external customers, including during tours.
Follow safety guidelines and use appropriate safety devices during operations.
Participate in continuous-improvement and quality initiatives to enhance production processes and meet quality and profitability metrics.
Maintain accurate records so traveler and quality documents are correct, parts are traceable, and quality issues can be addressed.
Demonstrate a basic understanding of Lean Manufacturing.
Participate with the Manufacturing Supervisor/Manager in setting and monitoring individual goals and cell performance metrics aimed at continuously improving operations quality.
Support divisional initiatives and requirements related to Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.