Location: Dublin
Duration: 1 Year Fixed Term
Job purpose:
As a QC and Manufacturing Technician at FIRE1, you’ll be a key player in our mission.
Your role will be to ensure our incoming components meet all requirements and to manufacture to the highest quality standards the devices used in our clinical trials, including a Class 3 implantable sensor manufactured in our onsite cleanroom and to receive, test and package an electronic belt.
While assembling the product is a key part of the role, we also rely on our QC and manufacturing technicians to help us continuously improve, executing and developing the full suite of systems that we will need as we grow and transition from pre-revenue to commercialization.
Long term, our QC and manufacturing technician team will be expected to be the process and equipment experts that help us transform our operations from clinical volumes to commercial volumes.
Responsibilities
- Strict compliance with Good Manufacturing Practices (GMP) and our procedures to uphold our commitment to quality and comply with legal regulations.
- Adherence to Environmental Health & Safety (EHS) requirements, promoting a safe and secure working environment.
- Sanitizing materials, equipment and cleanrooms, maintaining a strictly controlled and hygienic environment.
- Work in cleanroom and non-cleanroom ESD environments to inspect medical device raw materials, components and products both with and without the use of ergonomic microscopes.
- Manual assembly of the sensor in a controlled cleanroom environment with the assistance of ergonomic microscopes.
- Identify opportunities for improvements in associated procedures, equipment, inspections and general practices
- Liaise with Quality, Supply Chain, Engineering and Manufacturing Departments to troubleshoot issues
- Maintenance and upkeep of manufacturing environments, tools and equipment.
- Keep inspection equipment operating by following operating instructions; troubleshooting issues and/or calling for repairs
- Engage with the FIRE1 QMS to ensure delivery of the overall quality strategy & support the achievement of the business quality objectives
- Demonstrate and apply a solid understanding of Lean Manufacturing and related principles and work with other technicians and engineers on process improvement.
- Problem Solving: Apply problem-solving techniques and use various tools and test equipment to address production challenges.
- Technical Proficiency: Utilize technical manuals, specifications, drawings/diagrams, schematics, and verbal instructions to perform tasks.
- Assist with Engineering and Manufacturing training.
Experience & Education
Essential:
- Completed leaving certification
- Minimum of 3 years’ experience, ideally in a related field
- Curiosity, self-motivation, excellent communication
- Flexibility & adaptability to carry out different tasks based on daily needs
- The establishment and maintenance of good working and interpersonal relationships, fostering a positive team culture
- Skills to proactively drive operational / maintenance improvements
- Computer literacy
Desirable:
- Previous medical device or pharma experience or experience of FDA, GMP, QSR and ISO 13485 requirements is an advantage, especially Class III experience.
- Previous experience with laser welding, soldering processes or processes requiring a high level of manual dexterity.
- Experience in a Lean Manufacturing/ work environment of continuous improvement.
- While these experiences are helpful, it is not crucial as we provide comprehensive training to all our technicians.
Reporting:
Reports to Manufacturing Team Lead
To apply for this role please click below or email your CV to careers@fire1foundry.com