Job Description

Job Summary

The Assembler II is responsible for the assembly and production of high-quality medical devices across multiple product lines in accordance with established manufacturing standards and procedures. This role requires a solid understanding of quality system policies, manufacturing documentation, and Lean Manufacturing principles. The Assembler II works under the direction of a supervisor or lead to ensure all assembly operations are completed accurately, efficiently, and safely, while maintaining compliance with regulatory and company standards.

Job Responsibilities

• Assemble, inspect, and test medical devices on two or more product lines at or above standard production rates

• Follow written line procedures and reference Quality System Policies to ensure compliance with manufacturing and regulatory requirements

• Complete and maintain accurate documentation of all manufacturing operations, including Device History Records, Data Sheets, and Lot Control, in accordance with training and company policies

• Follow all instructions from the assigned supervisor or lead regarding priorities, work schedules, and job standards

• Adapt to changes in procedures and learn new processes as required by product line updates or technology changes

• Cross-train on various product lines and assist in training other assemblers as directed

• Support Lean Manufacturing initiatives by participating in continuous improvement activities and assisting in achieving production metrics

• Notify the supervisor or lead promptly of material shortages or equipment issues that may affect production

• Maintain a clean, organized, and safe work environment in compliance with all housekeeping and safety guidelines (including ergonomics, job rotation, tool handling, and preventive maintenance)

• Adhere to attendance standards and demonstrate flexibility by working overtime or alternate shifts as needed

• Use time effectively, remain focused on assigned tasks, and avoid disruptions that impact workflow or team productivity

• Participate in Shared Leadership activities such as Kanban Management, Calibration, and Metrics Board Maintenance

• Perform other essential duties as assigned by leadership

Job Requirements

• High School Diploma or equivalent preferred, with 1-2 years of previous medical device assembly or ISO-certified assembly experience

• In lieu of a High School Diploma, 2-3 years of prior medical device assembly or ISO-certified assembly experience required

• Ability to read, understand, and follow written and verbal work instructions accurately

• Strong communication skills to interact effectively with supervisors, leads, and team members via phone, email, and in person

• Basic math skills required (addition, subtraction, multiplication, division)

• Must be able to perform repetitive tasks according to set procedures, sequence, and pace

• Fine motor skills and excellent hand-eye coordination required for handling and assembling small parts and subassemblies

• Ability to work in a cleanroom environment while adhering to all cleanroom protocols and practices

• Knowledge of Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), and Lean Manufacturing principles preferred

• Ability to maintain confidentiality of proprietary information and processes

• Experience operating manufacturing and measurement equipment such as microscopes, test instruments, EFDs, ultrasonic welders, soldering irons, dial calipers, pressure gauges, and rulers

• Basic proficiency in MS Windows and site-specific computer programs following training

Job Tags

Shift work,

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