SEWING ASSEMBLER ( MEDICAL DEVICE- LIFE SCIENCES)

Aptyx•Charlotte, NC

2d•Onsite

About The Position

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.

Requirements

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.
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.
Fundamental computer skills to perform basic tasks related to production documentation.

Nice To Haves

Hand-sewing experience in any capacity (e.g., fashion design, seamstress, tailoring, upholstery, alterations).
Experience with assembly equipment such as lab oven, glue dispenser, heat gun, and soldering iron.

Responsibilities

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.