Our client, a medical device company in Cork are currently looking to recruit a Senior NPI Engineer, for Projects Team - Initial 23 month contract
Key Areas of Responsibility for the Senior NPI Engineer:
- Application of a prioritized approach in Value Centered Engineering toward achieving key opportunities in quality, service and cost.
- Works with Engineering leaders to deliver business objectives
- Responsible for assisting in the development of a world class-manufacturing group that is proficient in process improvement and problem solving manufacturing issues using Six-Sigma tools.
- Providing technical support on all product and process issues.
- Line performance monitoring, and the compilation and execution of structured event plans to remediate systemic issues that drive sub-optimal performance.
- Development and implementation of appropriate supporting documentation, SOPs and process work instructions compliant with current Good Manufacturing Practices (GMP)
- Driving technical improvements under the business’s Continuous Improvement Program (CIP).
- Transferring and implementing processes, either from development, or from another manufacturing facility.
- Provision of technical guidance for the Process / Maintenance Technicians and Manufacturing / Equipment Engineers on the team.
- Provide engineering support for New Product and New process Introduction, ensuring that all activities are completed and documented in accordance with New product Development Process.
- Process validation for products and processes; VP, IQ, OQ, PQ and associated documentation.
- Conduct Gauge R&R studies for products and new processes.
- Responsibility for projects (value stream and cross functional) as assigned by the company, including the scoping, approval, budgeting, specification, execution, qualification and handover as appropriate.
- Actively interfacing with cross-functional team members and 3rd party Vendors, and always practicing good team work in support of the day to day operating requirements, and in pursuit of achieving the business targets
- Fostering a work environment of continuous improvement that supports company Quality Policy, Quality System, and the appropriate regulations for the area they support, in particular ensuring that employees are trained to do their work and their training is documented.
- Compliance with Quality Management System requirements
- Continuous monitoring and reporting of variables that feed into the business performance metrics, and pro-active identification and resolution of issues around any deficits in same.
- Compliance with Environment Health and Safety (EHS) requirements
- Elimination and/or management of material risks on the production floor in co-operation with Supplier Quality engineers
- Undertaking, where appropriate, a Subject Matter Expert’s role for Regulatory Audit purpose
- Level 8 Degree in Engineering, Science or related discipline or equivalent.
- Minimum of 2 years’ experience in a Medical Manufacturing environment.
- Proven Project Management skills through the delivery of business critical projects.
- Strong communication and influencing skills with both internal and external agents.
- Capable of technical leading, influencing and providing technical direction to Engineers, Co-Op Students, Technicians and Operators as required.
- Capable of working as part of a multi-disciplined team in a dynamic and results motivated environment
- Demonstrable analytical & problem solving skills, a process improvement orientation, and the ability to handle multiple tasks in a fast-paced and results-oriented environment
- Excellent presentation and written / verbal communication skills
- Demonstrable ability to work autonomously
- A team player, with a flexible approach.
- Technological pioneer, willing to source, investigate and implement technological and automation advances
- Confident and effective decision maker, with a proven ability to negotiate and influence others.
For further information on this Senior NPI Engineer role in Cork please contact Deirdre Finnerty on 086 3073779 / email@example.com
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