Senior Process & R&D Engineering Lead

Collins McNicholas Group; Leinster; On-site; EUR 120,000 - 155,000; Full time

Job summary

Collins McNicholas Group is seeking an experienced Process / R&D Engineering Lead in Ireland to steer process development, scale‑up and manufacturing excellence for next‑generation medical devices. You will lead a multidisciplinary team across R&D, quality, and operations to translate design into robust production processes.

You will drive DFMEA/PFMEA, design transfer and lifecycle support, ensuring regulatory compliance and high-quality outputs.

Qualifications

• Bachelor's or Master's degree in Engineering (Manufacturing, Mechanical, Electrical, Biomedical or Materials Science preferred).
• At least 5 years' engineering experience in medical devices.
• Experience in senior/lead engineering roles and leading technical teams.
• Strong knowledge of ISO 13485 and FDA requirements.
• Experience with product development lifecycle including design transfer and commercialization.
• Experience with process development, manufacturing scale-up and process validation (IQ/OQ/PQ).
• Experience with DFMEA/PFMEA and risk management.

Responsibilities

• Lead, mentor and develop a team of engineers and technicians to drive technical excellence and continuous improvement.
• Lead development, scale-up and optimization of manufacturing processes for medical devices.
• Collaborate with Product Development to ensure manufacturability and smooth design transfer to production.
• Oversee validation strategies for IQ/OQ/PQ of processes, equipment and test methods.
• Ensure compliance with medical device regulations and quality standards; manage risk via DFMEA/PFMEA.
• Coordinate projects with cross-functional teams and external stakeholders to meet timelines.

Skills

Leadership

Team Development

Project Management

Lean Six Sigma

Regulatory Knowledge

Analytical Thinking

Education

Engineering degree (Bachelor's or Master's)

Tools

DFMEA

PFMEA

Design Transfer

Minitab

Job description

Collins McNicholas Group is seeking an experienced Process / R&D Engineering Lead in Ireland to steer process development, scale‑up and manufacturing excellence for next‑generation medical devices. You will lead a multidisciplinary team across R&D, quality, and operations to translate design into robust production processes.

You will drive DFMEA/PFMEA, design transfer and lifecycle support, ensuring regulatory compliance and high-quality outputs.