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Senior Engineer – Project, Advanced Operations
Our client, a medical device company in Cork is currently looking to recruit an Senior Engineer – Project, Advanced Operations for their site.
Job Description for Senior Engineer – Project, Advanced Operations:
- Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with new product development procedures.
- Project manage the introduction of new capital equipment and support the associated qualification and validation activities.
- Evaluate process layouts in terms of supporting new process integration while ensuring best utilisation of floor space ensuring optimum process flow.
- Ensure quality of process and product as defined in the appropriate operation and material specifications.
- Will assist in the selection of components and equipment based on analysis of specifications, reliability and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols.
- Support capital acquisition activities.
- Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches.
- Conduct MSA studies for new products and new processes.
- Provide training for manufacturing team members.
- Ensure adherence to GMP and safety procedures.
- Review and approval of validation documentation.
- All other duties as assigned.
- B.S in Mechanical Engineering or related engineering discipline with 2 or more years’ experience
- Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
- The individual should enjoy working in a fast paced, dynamic and results orientated team environment.
- Excellent Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams.
- Innovative thinker - should be able to envisage new and better ways of doing things.
- Excellent analytical skills, ability to plan, organise and implement concurrent tasks.
- Good knowledge of manufacturing processes, materials, product and process design.
- Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing.
- Experience in an FDA regulated or regulated industry beneficial.
- High level of PC Skills required.
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