Manufacturing Process Engineer - Start-upType: Permanent
Location: Galway
My client, an exciting medical device start-up based in Galway, is seeking a talented Manufacturing Process Engineer to join their team. The ideal candidate will have 3-6 years of industry experience, and experience with materials, chemicals, coatings, etc., would be an advantage but is not essential.
Responsibilities Provide day-to-day support to the line technician and product builders in troubleshooting equipment and process-related issues. Provide training to line technicians.Manage the manufacturing process, understand the process risks, and identify mitigations leading to improved yields and process efficiency.Work with equipment vendors to identify areas for process improvement.Create a strong culture of problem-solving using standard tools like DMAIC and Six Sigma.Create and follow a process development plan for the line equipment.Ensure all line equipment maintenance and calibration is up to date.Execute IQ/OQs for lab and production equipment.Communicate and update project activities using project management methodologies.Background & Qualifications Bachelor's, Master's, or PhD degree in Science, Mechanical Engineering, Manufacturing, Chemical Engineering, Biomedical Engineering, or other relevant engineering discipline.At least 3 to 5 years of work experience in a manufacturing or process development-related role in a medical device company.Experience with processes such as lyophilization, mixing, and dispensing would be an advantage.Demonstrated experience with GDP & GMP standards.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 organized, 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 in English.Extremely comfortable with hands-on and technical work.
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