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Job Summary
The Medical Device Assembler is responsible for producing high-quality medical devices, including pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related assemblies, within a manufacturing cell. Working under close supervision, this role performs assembly, repair, and testing operations in accordance with standardized procedures and quality standards. The Assembler ensures product traceability, supports continuous improvement initiatives, and maintains compliance with all applicable Quality Management System (QMS) and Environmental Management System (EMS) requirements. Job Responsibilities
Perform routine assembly, repair, and testing operations following standardized work procedures and instructions
Maintain accurate and up-to-date documentation for all manufacturing cell operations, including traveler and quality records
Communicate clearly and effectively with all levels of manufacturing management regarding ideas, issues, and process improvements
Demonstrate a positive and professional attitude when interacting with internal and external stakeholders, including visitors and auditors
Follow all safety protocols and utilize appropriate safety devices while performing manufacturing operations
Participate in continuous improvement and quality initiatives to enhance production processes, product quality, and operational efficiency
Ensure all products are traceable, accurately documented, and meet established quality standards
Demonstrate a foundational understanding of Lean Manufacturing principles and apply them to daily activities
Collaborate with the Manufacturing Supervisor or Manager in setting and monitoring individual goals and performance metrics to improve quality and output
Support all divisional initiatives and compliance efforts related to QMS, EMS, and other applicable regulatory requirements
Job Requirements
High School Diploma or equivalent required
Minimum of two (2) years of manufacturing experience required
Ability to read, comprehend, and follow written procedures and verbal instructions accurately
Basic proficiency with electronic data collection systems and computer software applications
Ability to handle and maneuver small components and parts with precision
Strong attention to detail and ability to make sound decisions and judgments with minimal supervision
Demonstrated ability to prioritize work, determine sequencing, and manage multiple tasks effectively
Commitment to maintaining product quality, accuracy, and compliance with safety and regulatory standards
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