Senior Process Development Engineer Position
Our client is seeking a Senior Process Development Engineer to join their R&D team. This key role will involve working closely with Operations, Quality, and Regulatory teams to develop and implement manufacturing processes within the manufacturing facility.
Key Responsibilities:
* Design and conduct engineering bench testing to investigate and develop appropriate manufacturing processes and specifications.
* Ensure process design and specifications are robust, reproducible, and capable of meeting all qualification requirements.
* Plan, develop, and execute test methods for process qualification (validation) testing of manufacturing processes.
* Manage sub-contract manufacturing partners through process qualification (validation) testing and manufacturing scale-up activities.
* Support and lead CAPA and NCR investigations from internal manufacturing and sub-contract manufacturing processes.
* Provide guidance to R&D Engineers, Technicians, and Product Builders.
* Compile technical documentation to support product development in accordance with ISO 13485 Quality Management System.
Required Skills and Qualifications:
* 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 ability to work effectively as a team member.
Additional Information:
For further information please contact James Cassidy at or call in confidence +353 86 020433