Project Engineer-NPI
Found in: beBee S IE - 4 weeks ago
Project Engineer, NPI â Contract
Innovation Centre â New Product Introduction
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Would you like to work in the top 10 most advanced factories worldwide for embedding New Technology as voted by The World Economic Forum? We are also shortlisted for the 2018 Research Innovation Awards by the Royal Irish Academy.
- Innovative âfail fastâ environment
- Strong team environment
- Exposure to leading technology
- Travel opportunities
- Remote working where suitable
- Flexible on-site hours (Half Day on Fridays)
- Spend up to 10% of your time on other initiatives â e.g. CSR, CPD, Environmental, etc.
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The Project:
This project is chartered to launch a series of new products from 2020 to 2025.
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The Role:
Daily your work in NPI will interact with Quality, Operations and the Design team to develop this system throughout its lifecycle from concepts to market launch. You will own either a process step in a project or a process technology for multiple projects at the Cork Innovation Centre. The project team will develop, qualify & launch a manufacturing process capable of making implants to safety, quality, service, and cost standards.
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The Ideal Candidate:
A planned and organised individual with strong technical or process knowledge/experience in a regulated industry. A strong team player that will own the delivery of elements within their process/technology area. You will need strong interpersonal skills, be able to collaborate effectively to resolve technical challenges.
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Principal Accountabilities:
Process development and value engineering including PFMEA
Process Characterisation
Process Qualification/Validation
Planning of key deliverables into action plans with the help of the Project Manager
Regular reporting on the status, performance and risks of your process / technology
Participate in DFM reviews with Design Team to minimize lifecycle cost
Minimise Environmental and Health & Safety effects of your work
Adhere to the companyâs procedures as detailed in the SOP manual
Support Regulatory Affairs with product submissions
All other duties as directed by direct manager
Required:
Third level Engineering degree or similar discipline.
1-3 yearsâ experience in product / process development with Class II / III medical devices or another regulated environment.
Self-motivated, with focus on Quality, Delivery and Cost.
Proven Root Cause analysis and problem-solving techniques.
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Desirable:
Exposure to Project Management
Knowledge of medical device quality & regulatory systems
Certified Six Sigma qualifications.
Knowledge of anatomy and physiology.
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