Medical Device Assembler

Job Description

Job Description

Medical Device Production Operator / Assembler

Schedule: Primarily 2nd Shift — Monday-Thursday, 2:30 PM-1:00 AM OR Friday-Sunday, 6:00 AM-6:00 PM (36 hours worked, paid for 40 hours)
Industry: Medical Device Manufacturing

Job Summary

We are seeking a Medical Device Production Operator / Assembler to join a manufacturing team producing high-quality medical devices. Working under close supervision, this position performs a combination of assembly, repair, testing, and production operations involving pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device assemblies.

The ideal candidate is detail-oriented, dependable, comfortable working with small components, and able to follow detailed written procedures and verbal instructions. This position offers the opportunity to work in a highly regulated medical device manufacturing environment while contributing to product quality, safety, and continuous improvement.

Key Responsibilities

• Perform routine assembly, repair, testing, and production operations on medical device components and assemblies.
• Assemble and handle small components and parts according to established procedures and manufacturing instructions.
• Follow standardized work instructions, SOPs, verbal instructions, and other applicable manufacturing procedures.
• Maintain accurate production records, travelers, and quality documentation to ensure product traceability.
• Review and complete required job documentation and ensure manufacturing cell records remain accurate and up to date.
• Perform quality checks and help identify and communicate quality issues that may impact production or finished products.
• Utilize electronic data collection systems and computer software as required for production activities and documentation.
• Follow all safety procedures and use appropriate safety equipment and devices during manufacturing operations.
• Participate in continuous improvement and quality initiatives designed to improve production processes, quality, and efficiency.
• Demonstrate a basic understanding of Lean Manufacturing principles and support efforts to improve cell performance.
• Communicate production issues, ideas, concerns, and solutions clearly to manufacturing supervisors and management.
• Prioritize work and determine the appropriate sequencing and timing of tasks based on production requirements.
• Support Manufacturing Supervisors and Managers in monitoring individual and manufacturing cell performance metrics.
• Maintain a positive and professional attitude when interacting with coworkers, management, internal customers, and visitors.
• Support Quality Management Systems (QMS), Environmental Management Systems (EMS), and other applicable regulatory requirements.
• Follow all applicable manufacturing, quality, environmental, and regulatory requirements.

Qualifications

• High school diploma or equivalent required.
• Ability to read, comprehend, and follow written procedures and work instructions.
• Ability to understand and follow verbal instructions.
• Strong attention to detail and commitment to producing high-quality work.
• Ability to handle and maneuver small components and parts.
• Basic computer skills and ability to utilize electronic data collection systems.
• Ability to prioritize multiple tasks based on importance and production requirements.
• Strong communication skills, both written and verbal.
• Ability to make sound decisions and judgments with limited supervision.
• Ability to work effectively in a team-oriented manufacturing environment.
• Willingness to follow safety procedures, quality requirements, and standardized processes.

What You'll Do

You will play an important role in the production of life-saving medical devices, performing hands-on assembly, testing, repair, documentation, and quality-related activities. Attention to detail, following procedures, and maintaining accurate documentation are critical to ensuring every product meets stringent quality requirements.

Keywords: Medical Device Manufacturing, Medical Device Assembly, Production Operator, Medical Device Assembler, Assembly, Pacemakers, ICDs, Implantable Medical Devices, Testing, Repair, Quality Control, Quality Documentation, Manufacturing, Production, SOPs, Work Instructions, Traceability, Lean Manufacturing, QMS, EMS, Electronic Data Collection, Small Components, Continuous Improvement, Safety, Regulatory Compliance