Principal Process Development Engineer

Principal Process Development Engineer

Our client, an established and high potential startup medical device company, is currently seeking 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 Principal Process Development Engineer will provide oversight of subcontract 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 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.Compile technical documentation to support product development in accordance with ISO 13485 Quality Management System.Skills/Experience: 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.
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