R&D & Process Engineering Lead - Medical Devices

Collins McNicholas Recruitment & HR Services Group; Athlone; On-site; EUR 90,000 - 120,000; Full time

Job summary

Collins McNicholas Recruitment & HR Services Group is seeking a Process / R&D Engineering Lead in Athlone, Ireland. The role leads a team of engineers and technicians, driving manufacturing excellence, process development, design transfer and validation from early stage to commercial production.

You will collaborate across Product Development, Quality and Manufacturing, shaping scalable processes, improving yield and performance while ensuring regulatory compliance and patient safety in a

Qualifications

• Bachelor's or Master's degree in Engineering (Manufacturing, Mechanical, Electrical, Biomedical or related).
• At least 5 years' engineering experience in medical devices.
• Previous experience in a senior/lead or supervisory engineering role.
• Strong knowledge of medical device regulations and quality standards (ISO 13485, FDA).
• Experience supporting product development lifecycle including design transfer and commercialisation.
• Proven experience in process development, manufacturing scale-up and process validation (IQ/OQ/PQ).
• Experience with engineering risk management, including DFMEA and PFMEA.
• Strong analytical and problem-solving skills, including statistics with Minitab.

Responsibilities

• Lead, mentor and develop a team of engineers and technicians to technical excellence and collaboration.
• Manage resources, project priorities and engineering deliverables to support manufacturing objectives.
• Lead development, scale-up and optimisation of manufacturing processes for medical devices.
• Collaborate with Product Development to ensure manufacturability and transition from prototype to production.
• Lead validation strategies for IQ/OQ/PQ and oversee equipment, tooling and test method validation.
• Ensure compliance with medical device regulations and quality systems in partnership with Quality.
• Develop and maintain project plans, schedules and cross-functional collaboration.

Skills

Leadership

Project management

Problem solving

Communication

Statistical analysis (Minitab)

Education

Bachelor's or Master's degree in Engineering

Tools

Minitab

DFMEA/PFMEA

Job description

Collins McNicholas Recruitment & HR Services Group is seeking a Process / R&D Engineering Lead in Athlone, Ireland. The role leads a team of engineers and technicians, driving manufacturing excellence, process development, design transfer and validation from early stage to commercial production.

You will collaborate across Product Development, Quality and Manufacturing, shaping scalable processes, improving yield and performance while ensuring regulatory compliance and patient safety in a