Assembly Technician

TurnCare™•Pequannock Township, NJ

10d

About The Position

The Assembly Technician is responsible for the precise assembly, testing, and packaging of medical devices in accordance with documented procedures and quality system requirements. This role supports daily manufacturing operations by ensuring products are built safely, accurately, and consistently to meet regulatory, quality, and customer requirements. The Assembly Technician plays a critical role in maintaining product quality and ensuring devices are manufactured in compliance with FDA and ISO 13485 standards.

Requirements

High school diploma or equivalent.
1+ years of experience in manufacturing, assembly, or a regulated production environment (medical device preferred).
Ability to read and follow detailed written instructions and drawings.
Strong attention to detail and manual dexterity.
Ability to stand, sit, and perform repetitive tasks for extended periods.
Ability to lift up to 40 lbs.
Ability to perform fine motor skills.
Ability to stand or sit for extended periods.
Basic computer skills for record keeping.

Nice To Haves

Experience in medical device manufacturing or another regulated industry.
Familiarity with ISO 13485 or FDA-regulated manufacturing.
Basic understanding of mechanical or electromechanical assemblies.

Responsibilities

Assemble medical devices and subassemblies according to work instructions, drawings, and specifications.
Perform mechanical, electromechanical, or manual assembly using hand tools, fixtures, and equipment.
Follow standard operating procedures (SOPs) and manufacturing work instructions.
Meet production schedules while maintaining quality and accuracy.
Perform in-process inspections and functional checks as required.
Identify, document, and communicate non-conformances or defects.
Maintain accurate production and quality records.
Adhere to all quality system, regulatory, and safety requirements.
Perform functional testing and verification per documented procedures.
Package finished devices according to packaging and labeling instructions.
Ensure traceability and lot control requirements are met.
Maintain a clean, organized, and safe work area.
Comply with EHS policies and procedures.
Participate in continuous improvement initiatives.
Provide feedback on work instructions and process improvements.
Support cross-training and team flexibility as production needs change.