Job Overview
We are seeking a highly skilled Process Development Engineer to join our team.
The successful candidate will be responsible for supporting the development and implementation of manufacturing and assembly processes associated with our pVAD catheter.
This includes design feedback & input, working with suppliers of catheter components, and collaborating with the device development and characterization team.
* Develops manufacturing processes, materials, and methods as part of the product development team.
* Designs, specifies, procures and qualifies process fixtures and equipment.
* Develops Work Instructions and other supporting documentation 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.
* Supports cleanroom setup, fit-out & validation.
* Evaluates relevant process & manufacturing technologies and strategically identifies opportunities to implement them.
* Executes project plans, tasks and deliverables. Manages time to meet project deadlines.
* Uses structured problem-solving techniques and statistical methods for data driven analysis and decisions.
Requirements
* 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: fixture and equipment design & specification, validation of processes and process equipment, development of Work Instructions and Calibration & Maintenance activities for manufacturing processes.