Principal Process Development Engineer

Our client an established and high potential start up medical device start up currently seeking a a Principal Process Development Engineer to join their team. Reporting to the CTO the Principal Process Development Engineer will hold a key role within the R&D team and work in collaboration with Operations, Quality and Regulatory teams to transfer, implement, validate and scale up manufacturing processes within the manufacturing facility. In addition, the Senior Process Development Engineer will provide oversight of sub‐contract manufacturing partners during routine production, scale up and validation activities.

Role/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

• 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