Job Description Job Description
Fiagon NA, LLC designs, develops, manufactures, and markets advanced medical devices for use in the healthcare industry. Our business is growing, and we are seeking an Injection Molding Setup Technician to support our increasing production demands and implementation of new medical device products.
The qualified candidate will be responsible for setting up, troubleshooting, and optimizing injection molding equipment and processes to ensure safe, efficient, and high-quality production. This role will collaborate closely with manufacturing, engineering, quality, and maintenance teams to support existing production and the successful launch of new products. There is a great amount of growth opportunity within the organization, and the right candidate will have exposure to a variety of manufacturing processes and opportunities to contribute to continuous improvement initiatives.
The responsibilities of this position include:
- Set up, start up, and troubleshoot injection molding machines, molds, auxiliary equipment, and related tooling
- Perform mold changes, material changes, and process adjustments to achieve production requirements
- Monitor molding processes and make necessary adjustments to maintain product quality and process stability
- Assist with development, documentation, and optimization of molding process parameters
- Support validation activities including IQ, OQ, and PQ efforts for new molds, equipment, and processes
- Work closely with Quality to identify and resolve molding defects and process issues
- Perform first-piece inspections and support in-process quality checks
- Maintain accurate setup records, process sheets, and production documentation
- Ensure equipment and tooling are properly maintained and report maintenance needs as required
- Support continuous improvement initiatives focused on safety, quality, productivity, and waste reduction
- Train operators on setup-related procedures and proper processing techniques as needed
- Follow all company safety procedures, GMP requirements, and quality system requirements
- Understand and comply with ISO 13485, FDA, and applicable regulatory requirements
- Provide technical support to manufacturing operations as needed
Position Requirements:
- Associate degree in Manufacturing Technology, Plastics Technology, Engineering Technology, or related field preferred; equivalent experience will be considered
- Minimum 3 years of experience setting up and troubleshooting injection molding equipment
- Experience with scientific molding principles and process optimization preferred
- Knowledge of molds, hot runner systems, auxiliary equipment, and material handling systems
- Ability to read and interpret technical drawings, work instructions, and process documentation
- Strong mechanical aptitude with the ability to diagnose and resolve processing and equipment issues
- Experience with medical device, highly regulated manufacturing, or cleanroom environments is a plus
- Familiarity with validation activities and documentation requirements preferred
- Ability to use measurement and inspection tools including calipers, micrometers, and gauges
- Strong attention to detail and commitment to product quality
- Ability to manage multiple priorities in a fast-paced manufacturing environment
- Excellent problem-solving, communication, and teamwork skills
- Ability to lift up to 50 pounds and stand for extended periods as required
Fiagon NA, LLC believes in the synergy of teamwork while maintaining an entrepreneurial spirit and providing an environment in which our associates develop and accomplish professional objectives. We offer a competitive salary and benefits package including health, life, retirement, and related benefits.
