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Job ID: JOB-12476
Senior Project Engineer – Galway

About the Job:
This role presents a great opportunity to lead a team who will collaborate with R&D and Commercial teams to deliver on strategic growth plans through the advancement of the current and future Product technologies. The role will support the initial Design stage gates while taking the lead to deliver the final stage gates. In all cases the role is expected to challenge and improve NPD Manufacturing systems as enablers to advance project execution.

Duties/Responsibilities:

• Plans, organizes, and delivers direction to Engineers and project teams across a diverse range of projects.
• Project manage cross-functional teams delivering on expansion of 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 involvement will include working with R&D and supply chain on supplier selection and qualification plans.
• Completing product and process changes through Process characterization, process validation, change control and documentation updates.
• Later design stage involvement will collaborate with Regulatory, Commercial and Production to prepare for regional registration and release to sales through coordination of BOM’s, labels and Manufacturing documentation.
• Troubleshooting with cross functional teams including Quality Engineering, Supply Chain, Manufacturing and R&D.
• Identification of product / process improvement opportunities through design stage gate review activities.
• Evaluate proposed changes to equipment / processes / components in relation to 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 Supervisor or Head of Function.

Education/Experience:

• Level 7 qualification in Engineering, Technology or Science along with a Trade certificate and appropriate experience.
• Level 8 qualification in Engineering, Technology or Science with the appropriate experience.
• Process Validation Knowledge essential for this role.

Specific Requirements:

• 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.
• Demonstrated experience of applying Lean tools / Six Sigma techniques to improve business processes & performances.
• Excellent understanding of EN ISO 13485:2016, MDSAP and FDA requirements as these apply to this role.
• Self-starter with ability to work independently under pressure and react quickly to changing priorities.
• Meticulous attention to detail while also conveying a sense of urgency.
• 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, risk assess.
• Proficiency in Microsoft Office software.

For further information on this role please contact Tommy McKeown on 086 0100903 / jobs@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Tommy McKeown

JOB-12476

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