Job Title: Medical Device Production Technician

Job Description

This role is responsible for producing high-quality medical devices in a predominantly cleanroom environment. The position involves formulating polymers and spray coating solutions, operating specialized machinery and microscopes, and performing precise assembly, inspection, and packaging activities in accordance with Good Manufacturing Practices (GMP).

Responsibilities

• Operate coating machines and other production equipment to manufacture medical devices according to defined specifications and GMP requirements.
• Formulate polymers, excipient solutions, and spray coating formulations, and perform testing to verify that formulations meet quality standards.
• Produce medical devices using a microscope and various equipment, ensuring accuracy and consistency throughout the process.
• Coat, inspect, and fold balloon catheters with close attention to detail and adherence to documented procedures.
• Follow manufacturing instructions carefully and update all relevant job documentation accurately to maintain full traceability.
• Perform product inspection using a microscope to identify defects and ensure products meet quality and safety requirements.
• Prepare products for packing and sterilization, including both sterile and non-sterile finished goods and semi-finished goods.
• Package sterile and non-sterile products in accordance with established protocols and quality standards.
• Identify supplies and materials that need to be replenished and communicate or act promptly to prevent production delays.
• Build components required for top-level work orders, ensuring correct assembly and documentation.
• Complete cleaning and housekeeping activities as required to maintain a clean, safe, and compliant work area.
• Work overtime and on weekends as needed to support high production demand and meet output goals.
• Adhere to cleanroom gowning and de-gowning procedures and handle chemicals safely while performing daily tasks.

Essential Skills

• High school diploma or equivalent education.
• At least 1 year of experience in the medical device industry, ideally in manufacturing or production.
• Experience working in a cleanroom environment with familiarity in gowning and de-gowning procedures.
• Ability to stand for the entire shift and perform repetitive tasks with consistent quality and focus.
• Willingness to work overtime and weekends to support production demands.
• Medium-level proficiency in English, with the ability to read and follow written manufacturing instructions and complete documentation accurately.
• Comfort working with and around chemicals while following safety procedures.
• Ability to follow GMP guidelines and standard operating procedures precisely.
• Basic mechanical aptitude to operate and monitor production machinery and equipment.

Additional Skills & Qualifications

• Microscope experience in a manufacturing or inspection setting is preferred.
• Experience with medical device assembly and production processes.
• Experience in pharmaceutical or aseptic manufacturing environments is an advantage.
• Familiarity with formulation work, including preparing and testing coating and excipient solutions.
• Strong attention to detail and ability to identify defects during microscopic inspection.
• Ability to maintain accurate records and documentation for traceability and compliance.
• Reliability and flexibility to adapt to changing production needs and schedules.

Why Work Here?

You will join a growing organization with a product that is forecasted for significant expansion as it moves toward FDA approval in the United States. The environment offers stability and long-term growth potential, with opportunities to build specialized skills in cleanroom production, formulation, and medical device manufacturing. You will work in a setting that values quality, compliance, and continuous improvement, providing a solid foundation for professional development.

Work Environment

The role is based primarily in a cleanroom environment where strict gowning and de-gowning procedures are followed to maintain aseptic conditions. Work involves standing for the entire shift, performing detailed tasks with microscopes, and operating coating machines and other production equipment. Team members handle chemicals and formulations while adhering to safety and GMP standards. The schedule includes regular shifts with the expectation of overtime and weekend work during busy periods. Breaks typically consist of one 30-minute unpaid lunch break and one