Electro-Mechanical Engineer is required to provide technical expertise and quality assurance by medical device client in County Offaly.
The successful professional will provide technical leadership and structured approach to problem solving for operations personnel involved in process engineering and development activities reporting to the Engineering Manager.
- Third Level Degree (honours preferred) in Electro-mechanical, Electronic, Mechanical or related Engineering discipline
- At least 2-5 years of relevant industry experience.
- Strong knowledge of electro-mechanical systems design and debug.
- Strong working knowledge of ISO 13485 and 21CFR820
- Highly experienced with International Regulations such as 60601
- Highly competent in leading and executing Process Validations.
- CAPA Ownership.
- Technical competency in reading schematics (both electrical and mechanical)
- Good planning and organizational skills
- Good interpersonal and communications skills
- Fluent written and spoken English with excellent record keeping and report writing skills.
- Expertise in interpreting complex and new situations, anticipates problems or opportunities, assess impacts / risks.
- Develops and implements solutions.
- Adapts to negotiate with peers for common agreement.
- Influences others, (departments & management)
- A true leader with the ability to work under own initiative.
- MS Office, including MS Project
- Willingness to travel to other Integra or vendor sites as part of duties.
Advantageous to have:
- Master Level Qualification.
- Review out of date component issues and lead the identification and specification review of alternatives and associated implementation efforts.
- CAPA Management & generation and adherence to GMP.
- Communicate project status and escalates issues to direct manager, program managers, internal and external partners in timely fashion and with appropriate process.
- Effectively manage the introduction of technology on product lines and process improvements.
- Manage health and safety aspects of equipment and provide user training.
- Support other departments as required, e.g., assist in analysis of customer returns, debug, root cause analysis, technical support for customers, conduct tests in the Laboratory, etc.
- Promptly contribute to the enhancement of compliance initiatives for areas of responsibility.
- Develop strong links with our sister plants to ensure effective on-going transfer and sharing of products, processes, and systems.
- Develop process improvement projects to achieve the highest quality standards in response to in-house quality levels and product complaints.
- Present, where appropriate, technical data to internal / external audit and inspection groups as required.
- Provide ongoing technical guidance to lead professional work teams, conducts special projects.
- Apply expertise to directly influence other outside departments.
- Regularly contributes to the development of new ideas and methods.
Our client offers career growth opportunities and great work benefits such as: Flexible working hours, Annual leave , Health insurance, Pension, Educational Assistance, Life Assurance, Canteen, Car Parking and more.
Send your CV in confidence to firstname.lastname@example.org