Senior Balloon Catheter Manufacturing En

ICDS Recruitment

Galway

Senior Balloon Catheter Manufacturing Engineer - Galway. In this role you will: • Become the technical expert for all balloon forming/catheter assembly processes. • Participate in the development and implementation of lean manufacturing processes. • Plan, budget and lead continuous improvement and /or new product/process-based projects. • Continually assess and review day to day manufacturing issues / practices, and strive for improvement by analysing, developing and implementing solutions that follow company, FDA and regulatory requirements. • Conduct validations on equipment, processes and products in line with regulatory standards. • Manage equipment, tooling, maintenance and calibration requirements. • Be 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. • Be capable of planning, organising 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. • Generate 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. The successful candidate will have a proven track record in production support & managing and delivering complex projects. Overall responsibility for projects, including identifying process improvement projects, design / development / implementation of new equipment / automation cost saving projects. Generation of project plans, budgets, timelines, etc. as well as daily support to manufacturing and the Engineering Department. Interested applicants should have: • Bachelor's Degree or Master's 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 catheter manufacturing processes required. • Experience in dealing with and managing cross-functional teams. • Demonstrated analytical problem-solving abilities. • 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. This job originally appeared on RecruitIreland.com.

1835 days ago