- Reference: GJ343353
- Job Type: Permanent
- Location: Galway, Galway City, Mayo
- Category: Medical Devices
- Can initiate and prioritize own workload and the work load of others and ensures it is aligned to department and site goals.
- Integration of Vertebral Documentation to our clients Standards
- Independently evaluates, selects, and applies standard technical techniques, procedures, and criteria, using judgement in making adaptations and modifications.
- Ensures all products and processes are developed in compliance with regulatory requirements.
- Continually assessing and reviewing day to day manufacturing issues, consistently striving for improvement by analysing, developing and implementing manufacturing techniques and materials to provide robust improvements in compliance with FDA and regulatory requirements.
- Leads complex Problem solving and cost improvement projects with cross functional teams.
- Supervision of others work including giving guidance to Technicians and managing their workloads as required.
- Using AutoCAD, Solid Works or similar design packages, create technical specifications / drawings as required.
- Works on special projects, writes ECN’s, executes validations and creates prototypes under broad direction.
- Performs other related duties and tasks as required.
- Educational experience of a Bachelor’s Degree in Engineering or technical field related to the department of assignment or industry.
- A minimum of 3 years’ experience in a medical device manufacturing environment in a similar role.
- Ability to apply and demonstrate analytical skills and scientific technical principles in problem solving and development.
- Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs
- 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.
- 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 & performance with good working knowledge of applying 5S and TPM programs. Green Belt or Black Belt certification an advantage.
- Demonstrated validation experience is highly desirable.
For a confidential discussion and more information on the role/company please contact Christopher O’Toole on 091-706713
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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