Key Role in Research and Development Team
We are seeking a highly skilled Senior Process Development Engineer to hold a key role within our R&D team and work collaboratively with Operations, Quality, and Regulatory teams to transfer, implement, validate, and scale up manufacturing processes within the manufacturing facility.
Main 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
* Develop and execute test methods for process qualification (validation) testing of manufacturing processes
* Manage subcontract manufacturing partners through process qualification (validation) testing and through manufacturing scale-up activities
* Support and lead CAPA and NCR investigations from internal manufacturing and subcontract manufacturing processes
* Provide guidance to R&D Engineers, Technicians, and Product Builders
* Maintain 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
* Proficiency in Microsoft Office, including MS Project or similar
* Strong interpersonal and organizational skills and ability to work effectively as a team member