Senior Manufacturing Project Engineer - Galway

Ref: 212 Date Posted: Tuesday 02 May 2023

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.

 

Responsibilities include;

•              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.  

or

•              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 annemarie@amfconsulting.ie