Sewing Assembler ( Medical Device- Life Sciences

Overview

The Assembler is responsible for producing components, subassemblies, and final assemblies according to approved documentation and quality standards. This role involves working in a Controlled Environment Room (CER), using microscopes and precision tools, and maintaining detailed records. Candidates with hand-sewing experience—whether professional or hobby-based (e.g., fashion design, alterations, seamstress, upholstery)—are strongly encouraged to apply due to the fine motor skills and attention to detail required.

• Follow all company safety, quality, and confidentiality protocols.
• Maintain positive and professional working relationships.
• Complete assigned work accurately and in a timely manner.
• Adhere to all applicable standard operating procedures (SOPs) outlined in the training matrix.

• Assemble components, subassemblies, or final products in accordance with released documentation.
• Use microscopes and precision hand tools (e.g., calipers, rulers) for detailed assembly and in-line quality checks.
• Operate various equipment including adhesive dispensers, UV curing units, hot boxes, tipping machines, and other production tools.
• Work within a Controlled Environment Room (CER) and maintain strict cleanliness protocols.
• Track and manage tools, materials, and manufacturing steps throughout the assembly process.
• Recognize and report quality issues or product defects to supervisors or engineers promptly.

• Perform complete station preparation and line clearance as per procedures.
• Ensure training is up to date and procedures are understood before beginning work.
• Fill out Lot History Records (LHRs) and other required documentation accurately and thoroughly.
• Complete daily, weekly, and monthly CER cleaning as assigned.

• Notify leads or supervisors of any unexpected issues such as equipment calibration concerns, expired materials, or elevated scrap rates.
• Halt production as needed to address safety or quality concerns.
• Report and support tool/equipment maintenance and repair requests.
• Assist in other areas of production as needed.

• High school diploma or equivalent required.
• Experience in a manufacturing, cleanroom, or assembly setting preferred.
• Experience using microscopes and hand tools for fine-detailed work.
• Preferred:
  Hand-sewing experience in any capacity (e.g., fashion design, seamstress, tailoring, upholstery, alterations).
• Strong attention to detail, manual dexterity, and ability to follow detailed instructions.
• Ability to work in a cleanroom environment under gowning and cleanliness requirements.

• Proven experience in hand sewing techniques or crochet work.
• Strong hand-to-eye coordination and manual dexterity, with the ability to work under a microscope when necessary.
• Ability to communicate (read, write, speak) in English.
• Ability to monitor own work to ensure precision, accuracy, and adherence to stringent quality standards.
• Familiarity with using a variety of measurement tools such as rulers and calipers.
• Basic mechanical ability and proficiency with hand tools such as tweezers, razor blades, scalpels, wire cutters, clippers, needle nose pliers, screwdrivers, and Allen wrenches.
• Experience with assembly equipment such as lab oven, glue dispenser, heat gun, and soldering iron.
• Fundamental computer skills to perform basic tasks related to production documentation.