- Become the technical expert for all balloon forming/catheter assembly processes.
- Participate in the development and implementation of lean manufacturing processes.
- 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 follow Merit Medical, FDA and regulatory requirements.
- Conduct Validations on equipment, processes and products in line with regulatory standards.
- Manage equipment, tooling, maintenance and calibration requirements.
- 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, 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.
- 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
- Bachelor's degree or Masters in an Engineering discipline e.g. Mechatronics, Mechanical, Biomedical or equivalent, with at least 2 years previous related experience in a Medical device or similar industry.
- Good working knowledge of catheter manufacturing processes required.
- 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 organisation 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.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales