JWR Employment Specialists are seeking an experienced Project Engineer to join a busy medical device manufacturing company in Co Clare.
Reporting to the Engineering Manager this newly created position will require a candidate with experience working in a Medical Device Manufacturing environment, with NPI project experience but also someone who will be able to put customer focus at the forefront. This is an exciting role for someone who is looking to develop their career in medical device manufacturing.
- Sales support through leading/supporting quotation and proposal activities with sales team, customers/ clients, inhouse engineering and appropriate external vendors
- 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.
- 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
- 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
- Lead Automation projects, equipment introductions – propose, plan, execute and close
- Identify and lead Continuous improvement and cost reduction initiatives
- Capability development
- Vendor sourcing / vendor setup; toolmakers, mould design/analysis services, metrology services/ equipment, component sourcing, post-moulding activities, outsourcing, software systems
- 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.
- 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.
- 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.
- Focus on scrap reduction, changeover optimization and OEE improvements to meet business objectives, inclusive product failure investigation
- Supports in the development and upgrade of engineering procedures, template and forms, to ISO9001 and ISO13485 standards.
- A Degree in a relevant engineering subject is required.
- Minimum of 5 years experience in a manufacturing environment required.
- NPI project experience.
- Experience and knowledge of injection moulding machines, process set up and optimization.