Job Overview
CrannMed is based in Galway, Ireland and was founded in 2018. The Company is committed to improve patient outcomes in a minimally invasive way and is actively working to develop leading edge devices and products to treat musculoskeletal conditions. The CrannMed team has a strong balance of commercial, clinical and product development skills and has built up a clinical network of world learning specialists and is determined to play a part in developing these solutions. We are a start-up but one on an exciting journey and growth plan.
CrannMed has an opportunity for a manufacturing engineer to support the operations team as we ramp up through pilot production to commercial launch.
Responsibilities
- Provide day to day support to the line technician and product builders, in terms of troubleshooting equipment and process related issues. Provide training to line technicians.
- Manage the manufacturing process, understand the process risks and identify mitigations leading to improving yields and process efficiency.
- Work with equipment vendors to identify area for process improvement.
- Create a strong culture of problem solving using standard tools like DMAIC and 6 sigma.
- Create and follow a process development plan for the line equipment.
- Responsible for all line equipment in terms of equipment, ensuring maintenance and calibration is up to date.
- Execution of IQ/OQs for lab and production equipment.
- Communicate and update project activities using project management methodologies.
Background & Qualifications
- Bachelors, Masters or PhD degree in Science, Mechanical Engineering, Manufacturing, Chemical Engineering Biomedical Engineering or other relevant engineering discipline.
- At least 3 to 5 years work experience in a manufacturing or process development related role in a medical device company.
- Experience with processes such as lyophilisation, mixing and dispensing would be an advantage.
- Demonstrated experience with GDP & GMP standards.
- Have an excellent knowledge of engineering materials used in medical device manufacture such as hydrogels, metals and polymers.
- A strong problem solver with knowledge and experience of DMAIC or other problem solving tools.
- Must be organised, demonstrate innovation and have a strong work ethic on individual projects and as part of a project team.
- Effective communication skills. Both verbal and written – English
- Extremely comfortable with hands-on and technical work
