Balloon Catheter Manufacturing Engineer
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. 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.
- 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, 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.
- Bachelor’s 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 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 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.
Merit Medical is an Equal Opportunities Employer
To apply for this job please visit recruiting.adp.com.