Reporting to the R&D Manager, the process development engineer will be involved in the project of transitioning a PTCA stent catheter from R&D to commercial phases. The engineer will work on both R&D and process development elements in this and other projects. The engineer will be technically competent as well as competent in problem solving, data analysis, report writing and project management skills.
- Manage projects transitioning from R&D to commercial phases.
- Complete evaluation, testing, analysis and reporting to establish performance of various products/processes.
- Schedule and manage development builds and testing.
- Specify, source, test and approve material.
- Prepare and lead reviews, including R&D design reviews.
- Create and maintain design-related technical information (lab notebooks, protocols, validations, manufacturing documents, etc.) to support design history file.
- Train operators/trainers in various new process steps.
- Understand and troubleshoot complex processing equipment.
- Work closely with manufacturing engineers during the handover period to commercial operations.
- Qualified to degree level in engineering, science or related discipline
- Knowledge of PTCA/stent catheter manufacturing processes essential
- Knowledge in the use/processing of a variety of materials (plastics, metal, adhesives, etc.)
- Understanding/working knowledge of relevant FDA/BSI standards and regulatory requirements
- Experience with design control and ISO13485
- Experience in risk management/IS014971
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