Mechanical Engineer Drug-Eluting Stent (DES)

Mechanical Engineer or similar required for all aspects of device testing and process development for a Drug Eluting Stent project in final stages of development. Must be hands-on, inventive, hard-working, meticulous. Will have strong involvement with drug-related aspects of project.

Experience with regulatory requirements for European approvals, process validations, precision engineering, working with chemical solvents would all be advantages. Good problem solving skills, and technical abilities are important, as are good report writing skills.

Project Description

The successful candidate will be coming into DISA Vascular’s Drug Eluting Stent (DES) Program at the final stages of development leading up to submission for European regulatory approval (CE Marking). The Stellium DES is currently undergoing clinical testing in a clinical trial in South Africa. The data from this trial together with all lab and animal trial work for device- and drug-related aspects of the product will be compiled in a Product Master File (PMF) and submitted to the European authorities. The successful candidate for this position will be responsible for a large component of the mechanical/device-related aspects of this submission. Existing production and testing methods have been developed – however a certain amount of process and test optimisation may still need to be developed by the engineer.

The following are the main short-term aspects of the project in terms of the chemist’s role:

Stent Production

• Train on current device-related production processes and test methods. During the validation phase, the engineer will be working closely with a chemist to produce product samples for batch testing and validations. All mechanical and related batch tests and record keeping will be done by the engineer (with the assistance of a small QM team).

• Review existing production Work Instructions. Finely tune (or change) existing processes to maximise production outcomes in terms of mechanical and visual measurable & qualities.

• Assist chemist in the set-up and improvement of equipment handling procedures and stations that ensure minimal risk of contamination and processing errors. Responsible for all hardware requirements for process optimisation and method development (eg drying rig for residual solvent control).

Process Validation

• Conduct a variety of process validations including testing sufficient numbers of book-end product sizes to demonstrate a robust and validated production process for certain output parameters (that require destructive testing to measure). Write up mechanical validations in final reports for PMF.

• Actively involved in risk management and analysis during the development phase.

Future developments

Future work in this role will involve potential process and design changes, experimentation with new product designs, preparation of pilot “clinical” samples for further preclinical (animal and in-vitro) studies and future clinical trials, as well as initiating entirely new product developments.

Send your CV and short motivation to damian@disavascular.com