Senior Process Development Engineer

Life Science Recruitment; Galway; On-site; EUR 65,000 - 80,000; Full time

Job summary

A medical device start-up in Galway is looking for a Senior Process Development Engineer to lead manufacturing process development and validation. Candidates should have a minimum of 5 years in the medical device industry and a relevant degree. Responsibilities include conducting engineering testing, managing contract partners, and supporting technical documentation. The role necessitates strong analytical skills and an understanding of catheter technologies.

Qualifications

• Minimum level 8 degree in Engineering or related technical field.
• At least 5 years related experience in the medical device industry.
• Experience in product development and process validation.

Responsibilities

• Design and conduct engineering bench testing for manufacturing processes.
• Manage sub contract manufacturing partners during process qualification.
• Compile technical documentation according to ISO 13485.

Skills

Engineering knowledge

Analytical problem-solving

Interpersonal skills

Organizational skills

Education

Level 8 degree in Engineering or related field

Tools

Microsoft Office

MS Project or similar

Job description

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 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 [e-mail] or call in confidence [phone].