Senior Manufacturing Specialist
1 week ago
Process Development Engineer Role
Job Description:This is a challenging opportunity to join an innovative medical device company as a Process Development Engineer. The successful candidate will be responsible for supporting the development and implementation of manufacturing and assembly processes associated with catheter-based medical devices.
Key Responsibilities:- Develops manufacturing processes, materials, and methods as part of the product development team, using in-house and external development paths
- Designs, specifies, procures and qualifies process fixtures and equipment
- Develops Work Instructions and other supporting documentation (e.g. calibration and maintenance) for manufacturing processes
- Executes process characterisation and validation activities
- Becomes a technical expert in the assembly and manufacture of our products, and provides technical guidance to other team members
A minimum of three years of medical device development experience, and have either a primary or Master's Degree in a relevant engineering discipline such as polymer, mechanical, manufacturing or biomedical engineering.
- Experience in fabrication and manufacture of catheter based medical devices; experience in large calibre delivery systems is an advantage
- Product and process development, and new product introduction skills in medical devices are a must. In particular: o Fixture and equipment design & specification o Validation of processes and process equipment o Development of Work Instructions and Calibration & Maintenance activities for manufacturing processes
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