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Senior Manufacturing Engineer - Contract
Our client, a medical device company in Cork are currently looking to recruit a Senior Manufacturing Engineer for their site.
The primary purpose of this job is to support a major Manufacturing Engineering Project.
The position is part of a team within the Engineering department that contributes to the overall business metrics. This position will provide project leadership on planning and execution of validation activities related to new product introductions, product transfers, new technologies and process changes continuous improvement, and risk mitigation initiatives and will also include liaison with other Design & Manufacturing sites to ensure all goals and targets of the manufacturing process are achieved
- Deliver key projects to the Value Stream which will positively impact on the key metrics.
- Competent in validation requirements on equipment introductions/processes/process changes.
- Responsible for performing process validation studies by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements.
- Process Validation for the transfer of processes within the facility.
- Preparation and project management of all line extensions/NPI including supporting documentation as reqd.
- Resolves validation issues of moderate scope with limited direct supervision.
- Focus on reduction of unit cost of production, through accountability for specific cells i.e. Consumable Cost, Scrap Cost and Cell Efficiency.
- Support business key metrics with ongoing process improvements and introduction of new technology.
- Support ongoing Safety Incident corrective actions and ERGO team initiatives/actions
Key Competencies Required
- Ability to manage multiple assignments or projects with sound analytical, troubleshooting, and problem solving skills.
- Flexible work ethic.
- Strong influencing skills.
- Excellent communication skills (written and oral).
- Problem solving skills – to assist in maintaining project progress and on design issues.
- Decision Making – required to make decisions on technical issues.
- Degree of responsibility – must be capable of taking direction and taking responsibility and ownership for systems.
- Excellent planning & organisation skills.
- Extent of confidentiality - discretion is essential in view of contact with outside parties, product development strategies, regulatory and sales information.
- Continuous Improvement Focus
Qualifications & Experience:
- Degree qualified in a relevant Engineering / Science discipline, with 2+ years relevant experience.
- Experience in regulated industry, FDA, ISO, etc.
- Experience in process Validation is essential
- Experience in CNC machining of Cobalt Chrome, Titanium & Plastics is desired
- Experience in investment casting or foundry process is desired
- Demonstrated ability to lead significant projects to completion, on time and within budget
- Demonstrated leadership skills and the ability to make effective decisions
- Six Sigma Certification (Green Belt / Black Belt) is desired
- Degree qualification in a relevant Science or Engineering discipline.
- Minimum 4 years experience in a similarly regulated environment and be able to demonstrate excellent communication skills with problem solving ability.
- Proven track record of raw materials qualifications.
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