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Job Summary
The Medical Device Assembler is responsible for the production, assembly, repair, and testing of high-quality medical devices within a manufacturing cell environment. Working under close supervision, this position supports the fabrication and assembly of products such as pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device components. The role requires strong attention to detail, adherence to safety and quality procedures, and commitment to continuous improvement within a regulated manufacturing environment. Job Responsibilities
Perform assembly, inspection, testing, and repair operations on medical device components according to standardized procedures and work instructions
Ensure job documentation for all manufacturing operations is accurate, complete, and up to date
Maintain traceability of all parts and materials in compliance with quality documentation standards
Follow established safety guidelines and use appropriate personal protective equipment (PPE) at all times
Communicate effectively with team members, supervisors, and management to identify and resolve production issues
Support continuous improvement and Lean Manufacturing initiatives to enhance efficiency, quality, and productivity
Participate in team meetings to establish and monitor individual and cell-level performance metrics
Contribute to achieving quality, safety, and production goals as defined by manufacturing management
Support compliance with Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Maintain a positive, professional attitude when interacting with internal staff and external visitors (e.g., customers or tours)
Job Requirements
High school diploma or equivalent required
Ability to read, comprehend, and follow written procedures and verbal instructions accurately
Basic understanding of electronic data collection systems and computer software tools
Excellent hand-eye coordination and fine motor skills for handling small parts and components
Ability to prioritize tasks and manage sequencing of work efficiently
Strong attention to detail with a commitment to producing high-quality, defect-free products
Ability to make sound decisions and judgments with minimal supervision
Preferred Knowledge and Skills
Basic understanding of Lean Manufacturing principles
Previous experience in a regulated manufacturing environment, preferably medical device production
Familiarity with documentation control, traceability, and quality assurance standards
Additional Job Details
Must be able to work in a cleanroom or controlled manufacturing environment
Must adhere to all safety, quality, and regulatory policies at all times
Work may require extended periods of sitting, standing, or repetitive motion
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