Senio Project Engineer

Our client, a leading design and contract manufacturing client who provide solutions for the medical device market are hiring for a Senior Project Engineer to join their team on site in Clare. This role is also commutable from Limerick and Galway. Reporting to the Engineering Manager, this is a customer facing role. The role will be inclusive NPI, Production, Continuous Improvement and supporting functions, across a range of sectors with a focus on medtech.

The core objectives of this role are as follows:

• Customer focused and customer facing
• Project engineering/ project management of programs and projects across the whole company; NPI projects, equipment, system upgrades, continuous improvement projects/activities etc.
• Equipment, tooling, automation and related services. This will include supplier management and identification, selection of services and delivery on same.
• Lead project management activities (e.g. project planning, tracking, risk management, reporting, communications etc.)
• Process engineering – process setup, validations, process improvements, procedure update and development

Duties & Responsibilities include but are not limited to:

Customer Focus

• Sales support through leading/supporting quotation and proposal activities with Synecco sales team, customers/ clients, inhouse engineering and appropriate external vendors
• Supports and may lead, customer audits and visits
• Customer facing; Owning and running external projects (incl Development & NPI projects). To include schedule, resourcing and budget management.
• Customer management – kick-off & regular meetings (set the tone/ take control), minutes, issue logs/ escalations, change management, and expectation management.
• Travel to customer sites/ prepare for customer visits

Project Management/ Project Engineering

• Leading team(s) of project reports on a project by project basis. Co-ordinates, and leads where necessary, across the engineering, quality, supply chain, finance, sales and production/ops teams
• NPI
  • Lead New Product Introduction (NPI) projects, in front of customer, following our ISO900 and ISO13485 procedures.
  • Lead full project management activities; NPI, capacity planning – new equipment/ resourcing requirements. (e.g. project budget/schedule planning, tracking, risk management, reporting, communications etc.)
  • Vendor management – including new mould builds, BOM outsourcing / pass through sales setup
  • Lead the entire process; from customer PO, vendor selection, mould design & builds, samples approvals, mould FAT, Trials, Studies, OQ/PQ, product specification development, transfer to production and production ramp planning.
  • Lead Automation projects, equipment introductions – propose, plan, execute and close; across Synecco cross functional teams
  • Identify and lead Continuous improvement and cost reduction initiatives – propose, plan, execute and close; across Synecco cross functional teams

Capability development

• Vendor sourcing / vendor setup; toolmakers, mould design/analysis services, metrology services/ equipment, component sourcing, post-moulding activities, outsourcing, software systems
• Liaises with cross functional teams, and external equipment/tooling or material vendors, in the selection, design & development of new (or upgrades to existing) equipment, tooling and materials.
• Co-ordinates the introduction of new processes, equipment (moulding, post-moulding, assembly, metrology) and materials including installation, calibration, EHS assessment debug, and all associated process and quality system documentation requirements including technical and process work instructions.

Process Engineering

• Leads the development and execution of experimentation and testing to enable characterisation, optimization and troubleshooting of key processes and equipment.
• Completes or leads the writing and release of process validation documentation including FMEA's, Validation Plans, protocols and reports.
• Co-ordinates execution and documentation of validation builds, co-ordinates testing of validation units and the compilation, analysis and reporting of the validation results.
• Provide strong technical support on process/product technologies to support production.

Continuous Improvement

• Demonstrates strong knowledge and application of Lean methodologies, and process improvement tools in identification and elimination of "waste" process steps and development of efficient, cost effective equipment and processes.
• Use Lean methodologies to drive continuous improvement focused on Quality, Cost, Material flow and layout.
• Focus on scrap reduction, changeover optimization and OEE improvements to meet business objectives, inclusive product failure investigation
• Support working with Enterprise Ireland (EI) and external stakeholders to lead Lean and Lean Transform (EI Terminology) initiatives.
• Support, upgrade and implement project management best practices; PMO – structures / templates, across projects life-cycles.

Quality System

• Supports in the development and upgrade of engineering procedures, template and forms, to ISO9001 and ISO13485 standards.
• May own and lead CAPA and NCE activities.
• Supporting all customer, FDA and NSAI visits and/or audits when required, supporting as a lead role in certain areas, from an Engineering perspective.

Education & Experience Required:

• A degree in a relevant engineering subject is required
• Minimum of 5 years’ experience in a manufacturing environment required.
• Customer facing experience
• NPI project experience
• Project engineering and project management experience
• Experience and knowledge of injection moulding machines, process set up and optimization.
• Experience in Blow Moulding would be a distinct advantage.
• Technical Writing Experience

For further information on this Project Engineer role in Clare please contact Caroline Kingston on 086 8395531 / caroline@hero.ie

Check out all our open jobs on our HERO Recruitment website – www.hero.ie
Please Note: HERO Recruitment will not forward your details to any company without your prior approval
#indeed

109984