Process Development Specialist
We are seeking a skilled and experienced Process Development Specialist to join our team. Reporting to the CTO, you will hold a key role within the R&D department and work in collaboration with Operations, Quality Assurance and Regulatory teams to transfer, implement, validate and scale up manufacturing processes within the manufacturing facility.
Key Responsibilities:
* Design and conduct engineering bench testing as required 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 through 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
Requirements:
* 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