Senior Process Development Engineer - Medical Devices

CREGG Group; Munster; In loco; Confidential; Tempo pieno

Descrizione del lavoro

CREGG seeks a Senior Process Development Engineer in Limerick to lead development, validation, and optimization of catheter-based manufacturing and packaging processes. The role focuses on microcatheter products within a regulated medical device environment.

You will drive IQ/OQ/PQ validations, TMV studies, and technology transfer, while mentoring junior engineers and collaborating across Manufacturing, Quality, R&D, Validation, and Supply Chain teams to ensure compliant, scalable processes and

Competenze

• Bachelor's Degree in Engineering or related discipline.
• Minimum 5+ years in medical device industry.
• Experience with microcatheter products or catheter-based tech.
• Strong TMV, IQ, OQ, PQ execution experience.
• Experience in packaging development and validation.
• Knowledge of ISO 13485 and FDA-regulated environments.

Mansioni

• Lead process development activities for new and existing medical device products, ensuring robust, scalable, and compliant manufacturing processes.
• Execute and document process validation activities including IQ, OQ, and PQ.
• Develop, execute, and report on TMV studies in accordance with regulatory and quality standards.
• Support development, optimisation, and validation of manufacturing processes for microcatheter products.
• Lead packaging development and validation activities, including integration into packaging systems and production lines.
• Collaborate with Manufacturing, Quality, R&D, Validation, and Supply Chain teams to ensure successful product launches and process improvements.
• Conduct process characterisation studies, root cause investigations, and continuous improvement initiatives.
• Generate and maintain technical documentation, validation protocols, reports, risk assessments, and engineering change documentation.
• Ensure all activities comply with FDA, ISO 13485, MDR, GMP, and internal quality system requirements.
• Provide technical leadership and mentoring to junior engineers and cross-functional teams.

Conoscenze

Process development

TMV studies

IQ/OQ/PQ

Packaging validation

Statistical analysis

Lean Six Sigma

NPI/Tech transfer

Design Controls

Project management

Formazione

Bachelor's Degree in Engineering

Descrizione del lavoro

CREGG seeks a Senior Process Development Engineer in Limerick to lead development, validation, and optimization of catheter-based manufacturing and packaging processes. The role focuses on microcatheter products within a regulated medical device environment.

You will drive IQ/OQ/PQ validations, TMV studies, and technology transfer, while mentoring junior engineers and collaborating across Manufacturing, Quality, R&D, Validation, and Supply Chain teams to ensure compliant, scalable processes and