Medical Device Process & R&D Lead — Scale & Innovate

Collins McNicholas Recruitment & HR Services Group; Athlone; On-site; EUR 90,000 - 130,000; Full time

Job summary

Collins McNicholas Recruitment & HR Services Group is seeking a Process / R&D Engineering Lead in Athlone, Ireland to guide engineering teams in developing and industrialising next-generation medical devices.

You will lead process development, manufacturing excellence and Design Transfer from early development to commercial production, shaping product design and ensuring regulatory compliance across ISO 13485 and FDA requirements.

Qualifications

• Bachelor's or Master's degree in Engineering (Manufacturing, Mechanical, Electrical, Biomedical or Materials Science).
• Minimum 5 years' engineering experience in the medical device industry.
• Experience in a senior/lead role with ability to lead and develop a technical team.
• Strong knowledge of medical device regulations and quality standards (ISO 13485, FDA).
• Experience supporting the product development lifecycle including design transfer and commercialization.
• Proven experience in process development, manufacturing scale-up and process validation (IQ/OQ/PQ).
• Experience with DFMEA and PFMEA and engineering risk management.
• Proficient in statistical analysis tools such as Minitab.

Responsibilities

• Lead a team of engineers and technicians to drive process development and manufacturing excellence.
• Oversee design transfer, Process Validation (IQ/OQ/PQ) and product commercialization.
• Develop project plans, allocate resources and manage cross-functional collaboration.
• Drive continuous improvement to reduce costs, improve yields and cycle times.
• Ensure compliance with ISO 13485, FDA and EU MDR standards.

Skills

Manufacturing leadership

Process development

Lean Six Sigma

Quality systems

Project management

Cross-functional collaboration

Data analysis

Stakeholder management

Mentoring

Education

Bachelor's or Master's degree in Engineering

Tools

Minitab

Job description

Collins McNicholas Recruitment & HR Services Group is seeking a Process / R&D Engineering Lead in Athlone, Ireland to guide engineering teams in developing and industrialising next-generation medical devices.

You will lead process development, manufacturing excellence and Design Transfer from early development to commercial production, shaping product design and ensuring regulatory compliance across ISO 13485 and FDA requirements.