Job Title: Senior Process Development Engineer
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Develop Innovative Medical Device Manufacturing Processes.
The successful candidate will play a key role in the R&D team and work closely with Operations, Quality, and Regulatory teams to develop and implement manufacturing processes within the facility.
Our ideal candidate will be responsible for designing and conducting engineering bench testing, ensuring process design and specifications are robust and reproducible, and planning and executing test methods for process qualification (validation) testing of manufacturing processes.
* 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
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 the ability to work effectively as a team member