Based in Galway my client is a world leader in their area and works through out the world improving patients’ everyday lives.
They are currently looking for a Senior Project Manufacturing Engineer to join their expanding team. If you are interested, please contact me for more information.
This is a super role which gives the opportunity to work with R&D, Quality and commercial teams to deliver strategic growth through advancing current and future product technologies.
• Plan, organise and deliver direction and support to Engineers and project teams across a diverse range of projects.
• Full Implementation and support to team Individual Development Plans
• Project manage cross-functional teams delivering on the expansion of the clients product portfolio across the globe while building Manufacturing Engineering capacity and reliability to meet demand.
• Lead NPD Manufacturing project tasks from product initial concept to Release to Sales to deliver Patient focused Product enhancements.
• Early design stage task support will include working with R&D, Quality Engineering and the Supply Chain teams on supplier selection, required Risk documentation (e.g., PFMECA) and qualification plans.
• Ensure prioritisation of Aerogen strategic projects and KPIs.
• Completing product and process changes through process efficiency, change control and documentation updates.
• Later design stage gate support, collaborating with Regulatory, Commercial and Production to prepare for Regulatory registration and release to sales through coordination of BOMs, Finished Good Labelling and Manufacturing documentation.
• Project Troubleshooting with cross-functional teams including Quality Engineering, Supply Chain, Manufacturing and R&D.
• Ensure Engineering compliance with relevant International Standards.
• Identification of product/process improvement opportunities through design stage gate review activities.
• Evaluate proposed equipment/processes/components changes about the impact on product quality, safety, stability, performance, or waste technology.
• Support all customer, FDA, and Regulatory audits.
• Perform other assigned tasks as directed by the Supervisor or Head of Function.
Education and experience
• Level 7 Degree/Diploma qualification in Engineering, Technology or Science with a Trade certificate and a minimum of 15 years of relevant experience.
• Level 8 Degree qualification in Engineering, Technology or Science with a minimum of 8 years of relevant experience.
• People management experience required and a proven track record of mentoring engineers in a collaborative working environment.
• Strong interpersonal, organizational and Project management skills with an ability to work effectively as a team member, influencer, and leader.
• Excellent understanding of EN ISO 13485, MDSAP and FDA requirements as these apply to this role.
• Self-starter with the ability to work collaboratively.
• Meticulous attention to detail.
• Effective communication and interpersonal skills; written, verbal and presentation. Must have the ability to communicate effectively and concisely at all levels of the company.
• Strong problem-solving capability, possessing a demonstrated capacity to identify problem root causes, deliver solutions, and risk assess.
• Proficiency in Microsoft Office software.
For more information please contact me on 0879728431 or email@example.com