Our client a manufacturing company in Galway are seeking a Senior Manufacturing Engineer (Projects)
for their site.
Senior Manufacturing Engineer (Projects)
The successful candidate will have a proven track record in managing and delivering complex projects. Overall responsibility for various projects, including identifying process improvement projects, design / development / implementation of new equipment / automation cost saving projects and development of auditable documentation packages relating to existing and new product lines.
The Candidate will be capable of working on their own initiative, scoping and investigating complex documentation challenges, development of project plans, budgets, timelines, etc. to bring that documentation up to our Standards and working as part of the team to execute that project plan and as required daily support to Manufacturing and the Engineering Department.
The candidate will be capable of leading cross functional project teams and liaising with senior management to ensure the successful completion of improvement and new product projects.
- Main Duties/Responsibilities:
- Lead complex projects from initial concept to final validation, aligned to PMBOK standards.
- Planning, budgeting and leading of continuous improvement and /or new product/process based projects.
- Taking responsibility for integrating the Vertebral Documentation to our Standards
- Developing structural, standards and guidance documents for developing a strong project delivery system across the operations teams, creating a clear Best Practise guidance strategy.
- Continually assessing and reviewing day to day manufacturing issues / practises, consistently striving for improvement by analysing, developing and implementing manufacturing techniques and materials to provide robust improvements in compliance with FDA and regulatory requirements.
- Working independently and leading project teams or working as part of an overall project team on specific assignment objectives, complex features and possible solutions.
- Plans, organizes and provides direction to engineers, technicians and Production personnel, as required.
- Provide input and direction to management on various technical issues.
- Generates ECN (Engineering Change Notices), Protocols and prototypes under broad direction.
- Performs other related duties and tasks as required.
- Bachelor's Degree in Engineering/Biomedical or Masters in a related discipline with at least 7 years previous related experience.
- People management experience is desirable.
- Good working knowledge of medical device materials and processes.
- Strong interpersonal and organizational skills and the ability to work effectively as a team member.
- Experience dealing with Marketing, Clinical and Regulatory personnel and enhancing feedback to device concepts.
- Demonstrated analytical problem solving abilities.
- Ability to manage cross functional teams.
- Good working knowledge of Microsoft Office.
- Good working knowledge of medical device quality & regulatory systems and medical device directives.
- Demonstrated experience of applying Lean tools / Six Sigma techniques to improve business processes & performances.
- Ability to travel as required (up to 10-20%).
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