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Senior Process Development Engineer

2 weeks ago

Galway, Galway, Ireland Life Science Recruitment Full time
Job Overview

We are seeking a highly skilled Principal Process Development Engineer to join our team at Life Science Recruitment. This role will be responsible for designing and developing manufacturing processes, ensuring they meet qualification requirements, and collaborating with various teams to transfer, implement, and validate these processes.

Responsibilities:
- Design and conduct engineering bench testing to investigate and develop appropriate manufacturing processes and specifications.
- 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.

Requirements:
- 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.
- Strong interpersonal and organizational skills and the ability to work effectively as a team member.