Life Science Recruitment
Job title:
Senior RandD Engineer
Company
Life Science Recruitment
Job description
Senior R&D EngineerOur 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
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 +353 86 020433
Expected salary
Location
Galway
Job date
Sat, 17 Aug 2024 01:52:03 GMT
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