Senior R&D Engineer

Our client an established and high potential start up medical device start up currently seeking a a Senior R&D Engineer to join their team. Reporting to the CTO the Senior R&D 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 R&D 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