Equiliem
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
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