Our client, a disruptive and high potential scale up, based and developed out of Galway is growing its operations and currently looking to hire a Manufacturing Process Engineer. The Company is committed to improving patient outcomes in a minimally invasive way and is actively working to develop leading-edge devices and products to treat musculoskeletal conditions.
Responsibility
1. 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.
2. Manage the manufacturing process, understand the process risks and identify mitigations leading to improving yields and process efficiency.
3. Work with equipment vendors to identify areas for process improvement.
4. Create a strong culture of problem-solving using standard tools like DMAIC and Six Sigma.
5. Create and follow a process development plan ensuring budget, risk, and timeline have a high level of focus placed on them.
6. Work closely with the R&D team to ensure their programs are also facilitated in the production plans.
7. Work with R&D on materials, process, and equipment improvement projects.
8. Create and update the existing master validation plan for the line equipment.
9. Responsible for all line equipment in terms of equipment, ensuring maintenance and calibration is up to date.
10. Execution of IQ/OQs for lab and production equipment.
11. Communicate and update project activities using project management methodologies.
Background & Qualifications:
1. Bachelor's, Master's, or PhD degree in Science, Mechanical Engineering, Manufacturing, Chemical Engineering, Biomedical Engineering, or other relevant engineering discipline.
2. At least 3 to 5 years work experience in a manufacturing or process development related role in a medical device company.
3. Experience with new equipment introduction (IQ/OQ) and process characterisation and validation.
4. Experience with processes such as lyophilisation, mixing, and dispensing would be an advantage.
5. Demonstrated experience with GDP & GMP standards.
6. Have an excellent knowledge of engineering materials used in medical device manufacture such as hydrogels, metals, and polymers.
7. A strong problem solver with knowledge and experience of DMAIC or other problem-solving tools.
8. Must be organised, demonstrate innovation, and have a strong work ethic on individual projects and as part of a project team.
9. Effective communication skills, both verbal and written – English.
10. Extremely comfortable with hands-on and technical work.
For more information on the role and a confidential discussion on the organisation please contact Chris O Toole.
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