Job Description

Position Summary

The Assembler performs direct manufacturing activities within the Production department to support the production of high-quality medical device components, subassemblies, and finished products. This position is responsible for following approved manufacturing procedures and quality requirements to ensure products are produced accurately, safely, and in accordance with customer requirements for quality, quantity, and delivery.

Essential Duties and Responsibilities

Quality, Compliance & Safety

• Follow the Aptyx Quality System, including all applicable SOPs and procedures identified within the employee's Training Matrix.
• Follow released manufacturing documentation and immediately notify the Lead or Supervisor of any discrepancies, conflicts, or unclear instructions.
• Confirm required training is current and procedures are understood before beginning work.
• Perform all work in accordance with applicable safety requirements and Aptyx policies.
• Identify product defects and communicate concerns to the Lead, Supervisor, and/or Engineer using the appropriate reject log or established communication process.
• Notify the Lead or Supervisor of any unanticipated nonconformance, including expired materials, overdue calibration, excessive scrap, or other conditions that may affect product quality.
• Stop production when necessary to prevent the continued processing of nonconforming product.

Assembly & Production

• Produce components, subassemblies, and finished assemblies according to released manufacturing documentation and established procedures.
• Perform in-process checks to verify that work has been completed correctly and meets established requirements.
• Use measurement tools such as rulers and calipers to verify product requirements.
• Operate assembly and production equipment, including adhesive dispensers, UV curing equipment, hot boxes, tipping machines, and other equipment as required.
• Maintain awareness of materials, tools, equipment, and procedures throughout the manufacturing process.
• Complete assigned work accurately and within established production requirements.
• Maintain a clean, organized, and safe work area.
• Assist with other production-related activities as assigned.

Documentation & Controlled Environment Room (CER)

• Prepare workstations and perform required line clearance in accordance with established procedures.
• Ensure daily line clearance is completed for each operation performed.
• Complete LHRs, production records, and other manufacturing documentation accurately and completely.
• Perform required daily, weekly, and monthly CER cleaning activities.
• Maintain appropriate control and organization of materials, tools, and documentation at the workstation.
• Notify the Lead or Supervisor when tools or equipment require repair or maintenance.

Teamwork & Professional Conduct

• Maintain positive and productive working relationships with coworkers and other departments.
• Demonstrate good judgment and professionalism when performing assigned responsibilities.
• Maintain confidentiality of company and product-related information in accordance with Aptyx policy.
• Communicate issues, questions, and production concerns promptly and professionally.

Qualifications

• Reliable, punctual, and dependable work ethic.
• Demonstrated ability to work effectively with diverse personalities.
• Good judgment and attention to detail.
• Ability to work independently while following established procedures and instructions.
• Ability to perform a variety of tasks on a daily, weekly, or monthly basis.
• Ability to work effectively in a team-oriented manufacturing environment.

Education

• High school diploma or equivalent, vocational training, or equivalent work experience.

Experience

• No prior experience required.
• Previous medical device, manufacturing, assembly, or controlled-environment production experience preferred.

Skills, Knowledge & Abilities

• Ability to read, write, and communicate effectively in English.
• Ability to accurately record measurements and production results.
• Good hand-eye coordination and manual dexterity.
• Strong attention to detail and ability to monitor work to ensure quality.
• Ability to work under a microscope.
• Basic mechanical aptitude and ability to understand the operation of manufacturing equipment.
• Ability to use measurement tools such as rulers and calipers.
• Ability to safely and effectively use hand tools, including tweezers, razor blades, scalpels, wire cutters, clippers, needle-nose pliers, screwdrivers, and Allen wrenches.
• Ability to operate a variety of assembly equipment, including lab ovens, adhesive/glue dispensers, heat guns, soldering irons, and similar equipment.
• Basic computer skills and ability to perform fundamental tasks within computer-based manufacturing systems.

Physical Demands & Work Environment

The physical demands described below are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential

Acknowledgement

I have received a copy of this job description, have read and understood it, and will complete all assigned duties and responsibilities. I recognize that the company reserves the right to modify this job description and that I will be informed of any and all modifications prior to their effective date.

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