Senior Process Development Engineer
Our client, an established start-up in the medical device sector, is seeking a Senior Process Development Engineer to join their R&D team.
Reporting to the CTO, the candidate will collaborate with Operations, Quality and Regulatory departments to transfer, implement, validate and scale up manufacturing processes within the facility and oversee sub-contract manufacturing partners during production 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 ***** 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
For further information please contact James Cassidy at or call in confidence .
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