Medical Device Assembler

Job Title : Medical Device Assembler

Job Location : Plano, TX

Shift hours : Mon - Fri / 6 : 00 am - 2 : 30 pm

Position Summary :

This role is responsible for the production of high-quality medical devices within a manufacturing cell. Working under close supervision, the Medical Device Assembler performs assembly, repair, and testing of pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related components. The position follows standardized procedures to ensure accuracy, compliance, and product integrity.

Key Responsibilities :

• Perform assembly, repair, and test operations on medical device components in accordance with documented procedures.
• Ensure job documentation and records are accurate, complete, and compliant with quality standards and traceability requirements.
• Operate within safety guidelines, utilizing appropriate protective equipment and tools at all times.
• Support continuous improvement and lean manufacturing initiatives to enhance efficiency, quality, and profitability.
• Conduct routine inspections and quality checks to ensure all products meet required standards.
• Communicate clearly with supervisors and team members to report issues, propose solutions, and support manufacturing goals.
• Participate in setting and achieving performance metrics aligned with departmental objectives.
• Adhere to all divisional initiatives supporting Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Skills & Qualifications :

Work Environment & Dress Code :

To ensure product integrity and safety, employees must comply with strict gowning and dress code requirements, including :