Sewing Assembler

Position Summary

The Sewing Assembler performs precision sewing and assembly activities within the Production department to manufacture high-quality medical device components, subassemblies, and finished products. This position is responsible for following approved manufacturing procedures, specifications, and quality requirements to ensure products are produced accurately, safely, and in accordance with customer requirements for quality, quantity, and timeliness.

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, drawings, specifications, and procedures when performing assigned work.
• Confirm required training is current and procedures are understood before beginning work.
• Identify defects, inconsistencies, or other quality concerns and communicate them promptly to the Lead, Supervisor, and/or Engineer using the appropriate reject log or established communication process.
• Follow all applicable safety requirements and Aptyx policies.
• Notify the Lead or Supervisor of any unanticipated nonconformance, including expired materials, overdue calibration, excessive scrap, equipment issues, or other conditions that may affect product quality.
• Stop work when necessary to prevent the continued processing of nonconforming product.

Sewing & Assembly

• Perform precision hand sewing and other sewing assembly operations according to released manufacturing documentation and established procedures.
• Produce components, subassemblies, and finished assemblies to required specifications and quality standards.
• Perform sewing operations requiring consistent stitch placement, tension, alignment, and overall workmanship.
• Inspect completed sewing work to ensure proper construction, appearance, dimensions, and adherence to established requirements.
• Perform in-process checks and utilize measurement tools such as rulers and calipers as required.
• Use appropriate hand tools and assembly equipment to complete manufacturing operations.
• Operate equipment such as lab ovens, adhesive/glue dispensers, heat guns, soldering irons, and other equipment as required.
• Maintain control and 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.

Documentation & Production Controls

• 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, inspection records, and other manufacturing documentation accurately and completely.
• Maintain appropriate identification, organization, and control of materials and work-in-process.
• Perform required daily, weekly, and monthly Controlled Environment Room (CER) cleaning activities.
• Notify the Lead or Supervisor when tools or equipment require repair, maintenance, or replacement.

Teamwork & Professional Conduct

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

Qualifications

• Reliable, punctual, and dependable work ethic.
• Strong attention to detail and commitment to producing precise, high-quality work.
• Demonstrated ability to work effectively with diverse personalities.
• Good judgment and ability to follow detailed instructions and established procedures.
• Ability to work independently while also contributing effectively within a team environment.
• Ability to perform a variety of tasks on a daily, weekly, or monthly basis.

Education

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

Experience

• Proven experience with hand sewing techniques, crochet work, or other detailed needlework requiring precision and manual dexterity.
• Previous medical device, manufacturing, or assembly experience preferred.

Skills, Knowledge & Abilities

• Ability to read, write, and communicate effectively in English.
• Strong hand-eye coordination and manual dexterity.
• Ability to perform repetitive, precision sewing operations while maintaining consistent quality.
• Ability to work under a microscope when required.
• Ability to monitor own work for precision, accuracy, and adherence to stringent quality standards.
• Ability to use measurement tools such as rulers and calipers.
• Basic mechanical aptitude and ability to use a variety of hand tools, including tweezers, razor blades, scalpels, wire cutters, clippers, needle-nose pliers, screwdrivers, and Allen wrenches.
• Ability to safely operate assembly equipment such as lab ovens, adhesive/glue dispensers, heat guns, soldering irons, and similar equipment.
• Basic computer skills and ability to perform fundamental tasks related to production documentation and manufacturing systems.

Acknowledgement