Medical Device Machine Operator II

Cynet Systems•Scarborough, ME

About The Position

This position produces high-quality medical devices within a manufacturing cell. Under close supervision, the operator may perform a combination of assembly, repair, and testing operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device assemblies. Assignments follow specified or standardized procedures, and work is closely and continually reviewed. The role requires maintaining accurate and current job documentation, communicating ideas and issues clearly to manufacturing management, following safety guidelines, and contributing to continuous improvement and quality initiatives. The operator maintains records to ensure production and quality documents are correct, parts are traceable, and quality issues can be addressed. The position also supports divisional initiatives and applicable quality, environmental, and regulatory requirements.

Requirements

High school degree or equivalent.
Ability to read, comprehend, and follow written procedures and understand and follow verbal instructions.
Ability to use electronic data collection systems and computer software packages.
Ability to handle and maneuver small components and parts.
Ability to make critical decisions and judgments with minimal supervision.

Responsibilities

Perform assembly, repair, and testing operations on pacemakers, ICDs, leads, and related medical device assemblies.
Ensure job documentation for manufacturing cell operations and functions is 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 all operations.
Participate in continuous improvement and quality initiatives to enhance production processes and achieve quality and profitability metrics.
Maintain accurate traveler and quality records, ensure parts are traceable, and support resolution of quality issues.
Participate with the Manufacturing Supervisor or Manager in setting and monitoring individual goals and cell performance metrics.
Support divisional initiatives and requirements related to Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory matters.
Prioritize work by sequencing and timing jobs according to precedence and importance.