A Major Medical Devices Company in Galway City, Ireland wish to recruit a suitably qualified person for the following post:
Generation of project plans, budgets, timelines, etc. as well as daily support to manufacturing and the Engineering Department. The candidate will be capable of being part of, or leading cross functional project teams and liaising with other key personnel including senior management so as to ensure the successful completion of improvement and / or new product projects.
Lead complex projects from initial concept to final validation.
Planning, budgeting and leading of continuous improvement and /or new product/process-based projects.
Continually assess and review day to day manufacturing issues / practises, and strive for improvement by analysing, developing and implementing solutions that are in compliance with Company, FDA and regulatory requirements.
Ensure that all products/processes are developed in compliance with regulatory requirements / best practise.
Capable of working independently and leading project teams or working as part of an overall project team on specific assignment objectives, complex features and possible solutions.
Capable of planning, organizing and providing direction to other team members including engineers, technicians and production personnel, as required.
Provide input and direction to management on various technical issues.
Generates ECO's (Engineering Change Orders), protocols, reports and prototypes under broad direction.
Using AutoCAD, Solid Works or similar design package, create technical specifications as required.
Performs other related duties and tasks as required.
Bachelors Degree or Masters in an Engineering discipline e.g. Mechatronics, Mechanical, Biomedical or equivalent, with at least 3 years previous related experience in a Medical device or similar industry.
Good working knowledge of processes' like Centreless Grinding; Point Coil Winding and other "Coiled Guide wire" assembly processes and materials would be an advantage.
Experience dealing with, and managing Cross functional teams including Marketing, Production, Clinical and Regulatory personnel, to develop and implement solutions over a wide and varied scope.
Strong interpersonal and organizational skills and the ability to work effectively as a team member.
Demonstrated analytical problem solving abilities.
Good working knowledge of Microsoft Office including MS Project, Excel, Word etc. or similar.
Demonstrated 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 & performance with good working knowledge of applying 5S and TPM programs. Green Belt or Black Belt certification an advantage.
A very attractive Salary/Benefits Package is on offer and negotiable
Please forward your CV immediately to:
For informal enquiries, please ring Christy O'Hara on 087-9473404 or 00353 87 9473404 if outside Ireland