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Senior Process Engineer | Galway

Our client a major multinational here in Galway are looking to hire a Senior Process Engineer.


RESPONSIBILITIES

  • Collaborate with the cross-functional development team(s) to bring products and processes to market on time, to budget, and with zero quality/compliance issues.
  • Work with R&D, Marketing, Operations, and others to ensure process installation activities stay on track.
  • Troubleshoot issues with new processing technologies & equipment.
  • Transfer of new device assembly requirements to manufacturing with hands-on technical support: including developing Six Sigma processes/documentation for routine clinical and/or commercial production.
  •  In partnership with equipment vendors and the Operations team, identify opportunities for improving overall equipment performance. 
  • Liaise with external equipment & tooling development partners as required to ensure they meet agreed project objectives.
  • Assist in the identification of preferred vendors for assembly automation and/or manual assembly.
  • Develop User Requirements Specification (URS) and work with the Procurement team to award business. Conduct regular project/cost reviews with partners to ensure they stay on track for solution delivery.
  • Identify potential roadblocks and either resolve them or escalate them to a level where they can be addressed.
  • Provide regular partner status updates back to the leadership team.
  • Represent the process engineering team at the Operations sites.
  • Ensure the project is being sufficiently resourced/prioritized to achieve success.
  • Forward plan with the local team to ensure facilities are ready in time for product introduction.
  • Ensure that qualification parameters and process validation are complete for Medical Device assembly requirements.
  • Follow-up planning with the local team to ensure the projected ramp is met (materials, staff, support, etc).
  • Costs: Work with subject matter experts to ensure that defined budgets are in place for services and tools/equipment.
  • Manage budget request documents for project-related spending.
  • Monitor spend rate v plan and ensure it stays on track.
  • Lead process modeling, data trending, and advanced statistical & process analysis – present data/metrics to teams.
  • Implement process improvement strategies to improve quality, reliability, and/or reduce cost.
  • Risks: Develops plans with core members to eliminate and/or mitigate process risk. If risks cannot be mitigated within the core team, determine appropriate means to communicate and elevate issues to appropriate individuals within the organization.
  • Review identified risks for operations non-conformances, change controls and implement appropriate CAPAs. Assess & present cost implications.
  • Comply with worldwide medical device regulations including U.S. FDA, company policies, and Good Manufacturing Practices.
  • Maintain a safe and professional work environment.

REQUIREMENTS

  • Bachelor’s degree in Engineering, Science or equivalent from an accredited university with a minimum 7 years experience as a Process Engineering subject matter expert in product development or medical device manufacturing environment.
  • Experience in new product introductions and collaborating with cross-functional teams to achieve successful launches.
  • Ability to work in a matrixed and geographically diverse business environment. Strong engineering & leadership skills, including the ability to set goals and provide constructive feedback respectfully to build positive relationships and improve business results.
  • Process/equipment development and optimization experience in high volume, automated medical device assembly environment.
  • Ability to work effectively within a team in a fast-paced changing environment. 
  • Excellent written and verbal communication skills to support virtual program management requirements & to present updates at multiple levels in the organization.
  • Strong organizational skills including attention to detail and multi-tasking abilities.
  • International Travel as required

For more information on this role and a confidential discussion please contact Michelle Mc Inerney on

091 706 717 or email michelle.mcinerney@collinsmcnicholas.ie