Job Title:
* Senior Process Development Engineer
About the Role:
* We are seeking an experienced Senior Process Development Engineer to lead our R&D team in transferring, implementing, validating and scaling up manufacturing processes within our facility.
* The successful candidate will collaborate with Operations, Quality and Regulatory teams to ensure process design and specifications are robust, reproducible and capable of meeting all qualification requirements.
* You will plan, develop and execute test methods for process qualification (validation) testing of manufacturing processes.
* Additionally, you will manage sub-contract manufacturing partners through process qualification (validation) testing and through manufacturing scale-up activities.
* Your expertise will be invaluable in supporting and leading CAPA and NCR investigations from internal manufacturing and sub-contract manufacturing processes.
* You will also provide guidance to R&D Engineers, Technicians and Product Builders.
* Finally, you will compile technical documentation to support product development in accordance with ISO 13485 Quality Management System.
Requirements:
* A minimum level 8 degree in Engineering or related technical field.
* At least 5 years previous related experience in the medical device industry.
* Experience in product development and process validation processes.
* Excellent knowledge of catheter technologies including manufacturing of reinforced (braided and coiled), steerable polymer shafts.
* Demonstrated analytical problem-solving abilities.
* Good working knowledge of medical device materials and processes.
* Good working knowledge of Microsoft Office including MS Project or similar.
* Strong interpersonal and organizational skills and the ability to work effectively as a team member.