Provide daily support to line technicians and product builders, focusing on troubleshooting equipment and process-related issues. Deliver training to line technicians as required.
Oversee the manufacturing process, assess process risks, and implement mitigations to enhance yields and overall process efficiency.
Collaborate with equipment vendors to identify and implement process improvements.
Foster a strong problem-solving culture by utilizing standard methodologies such as DMAIC and Six Sigma.
Develop and adhere to a process development plan for line equipment.
Oversee all line equipment, ensuring maintenance and calibration schedules are maintained and up to date.
Execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols for laboratory and production equipment.
Communicate and update project activities using established project management methodologies.
Background & Qualifications
Bachelor’s, Master’s, or PhD in Science, Mechanical Engineering, Manufacturing, Chemical Engineering, Biomedical Engineering, or a related engineering discipline.
3 to 5 years of experience in a manufacturing or process development role within a medical device company.
Experience with processes such as lyophilization, mixing, and dispensing is an advantage.
Proven experience with Good Documentation Practice (GDP) and Good Manufacturing Practice (GMP) standards.
In-depth knowledge of engineering materials used in medical device manufacturing, including hydrogels, metals, and polymers.
Strong problem-solving skills with experience in DMAIC or similar problem-solving tools.
Must be organized, innovative, and demonstrate a strong work ethic in both independent and team- based projects.
Expected salary
Location
Galway
Job date
Sun, 01 Sep 2024 05:50:41 GMT
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