Senior Manufacturing Project Engineer with medical devices process validation experience required for key role with global medical devices R&D company in Galway. As a result of global expansion, my client is keen to hire a Senior Project Engineer to manage the expansion of Supplier capacity & capabilities. Collaborating with the Supply Chain & global commercial teams, you will project-manage cross-functional multi-site teams to deliver on strategic growth plans by challenging & improve manufacturing systems to meet demand. This is akey role within the organisation and reports into Associate Director level.

Responsibilities:

  • Lead cross functional teams consisting of Supplier Quality, Supply Chain and Design in Supplier qualification projects to meet Quality, Cost, and service requirements
  • Lead the validation strategy and execution for process change, new product, new material and capacity expansion at supplier sites
  • Working with Supply chain on strategic sourcing projects to meet long-term capacity
  • Taking the lead in troubleshooting complex technical issues with a cross functional team in a process sustaining or improvement activity
  • 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 Supplier capacity and reliability to meet demand
  • Develop relationships and interact directly with customers by responding customer change requests
  • Participate in supplier selection process through RFQ support, risk assessment and approval of new vendors for dual source on new / additional component supply
  • Support Supplier Quality by participating in Supplier audits
  • Support all customer, FDA and NSAI audits when required
  • Perform other assigned tasks and support all aspects of Manufacturing Engineering as directed by Head of function

Requirements:

  • Level 8 qualification in Engineering, Technology or Science with minimum 8 years experience OR Level 7 qualification in Engineering, Technology or Science along with a Trade certificate and minimum 15 years experience

  • Process Validation Knowledge essential

  • People management experience required

  • A proven track record of mentoring engineers in a collaborative working environment

  • Strong 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

  • 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

  • Flexibility to travel to vendor sites to support service and project activities

  • Proficiency in Microsoft Office software

  • Knowledge of polymers and Moulding is an advantage

Please contact Emer Smith to discuss in confidence

00353578638188

emer@emtechrecruitment.ie 

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