- Reference: CJ43813
- Job Type: Permanent
- Location: Munster, Waterford
- Category: Engineering, Technical & Manufacturing
Self-motivated Manufacturing/NPI Engineering with excellent communication, organisation and co-ordination skills to lead and or support the initiation, planning, execution and monitoring/control of assigned projects and provide engineering support to production through continuous improvement methodologies.
- Lead or participate in projects to successfully initiate, plan, execute, monitor/control and close significant cross-functional projects.
- Medical project management policies and procedures.
- Delivering engineering projects to scope, schedule and cost baselines.
- Participate in group brainstorming sessions to feed new project pipeline.
- Manage the Asset Lifecycle for new equipment (URS/RQ/IQ/OQ/PQ/PPQ).
- Responsibility for project capital and expense spend.
- Undertake in-depth feasibility studies to support new project business case, SOW and funding for the procurement of capital equipment.
- Develop new opportunities through discussion within Sales teams or with customer technical teams.
- Responsibility for driving customer initiated projects forward.
- Responsibility for New Product Introduction projects from initial customer contact and specification review to creation of production documentation including, routings, boms, drawings,labels etc.
- Carryout out design verification and process validation, ISO and FDA standards.
- Generate and seeks approval of product and process MVP, IQ, OQ, PQ & PPQ validation protocols and reports.
- Negotiate with functional managers to acquire project team members.
- Deliver continuous improvement projects through Root Cause Analysis methodologies, A3 problem solving, Kiazen events and value stream mapping.
- Support the quality concepts inherent in the business philosophies of the company.
- Create and maintain Device Master Record (DMR) Documentation through the order entry and ECO process.
- Influence innovative qualification methodologies to apply appropriate statistical and validation techniques based on failure model and overall risk.
- Develop strategic collaborations across functions, business units and geographic boundaries to achieve effective outcomes over the long-term.
- College graduate with degree in Engineering, or equivalent experience.
- Demonstrated relevant experience in a similar role
For a confidential discussion and more information on the role, please contact Emer O’ Callaghan on 021 4911061 or email firstname.lastname@example.org
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