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

Process / R&D Engineering Lead

Medical Devices | Engineering Leadership | Process Innovation

Location: Athlone, Ireland

We are seeking a Process / R&D Engineering Lead to join an ambitious engineering and manufacturing team within the medical device industry.

This is an exciting opportunity to play a pivotal role in the development, optimisation and industrialisation of next-generation medical devices. You will lead a team of engineers and technicians, driving manufacturing excellence, technical innovation and successful product transfers from early-stage development through to commercial production.

Combining technical expertise with strong leadership and project management skills, you will help shape manufacturing processes, influence product design and ensure the successful delivery of high-quality, compliant and commercially viable medical devices.

If you enjoy solving complex engineering challenges, developing people and seeing your work make a tangible difference to patient outcomes, this could be the opportunity for you.

The Opportunity

Reporting to the Head of Operations, you will lead engineering activities across process development, R&D and manufacturing, ensuring new products and processes are robust, scalable and ready for commercialisation. You will work closely with cross-functional teams across Product Development, Quality, Manufacturing and Operations, playing a key role in driving projects forward and ensuring a seamless transition from product design to production.

Key Responsibilities

Engineering Leadership & Team Development

• Lead, mentor and develop a team of engineers and technicians, fostering a culture of technical excellence, collaboration and continuous improvement.
• Manage resources, project priorities and engineering deliverables to support business and manufacturing objectives.
• Encourage innovation, accountability and effective problem-solving across the engineering team.

Process Development & Manufacturing Excellence

• Lead the development, scale‑up and optimisation of manufacturing processes for innovative medical devices.
• Drive improvements in yield, productivity, cycle times and manufacturing costs using Lean, Six Sigma and other continuous improvement methodologies.
• Identify opportunities to improve process capability, efficiency and product quality.

Product Development & Design Transfer

• Collaborate with Product Development to ensure products are designed with manufacturability, scalability and commercial production in mind.
• Lead Design for Manufacturability (DFM) activities and support the transition from prototype development to commercial manufacturing.
• Manage the formal Design Transfer process, ensuring products and processes are successfully transferred into production.
• Support projects throughout the product lifecycle, from concept development and design through to commercialisation.

Process Validation & Technical Excellence

• Lead validation strategies and activities, including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
• Oversee the validation of manufacturing processes, equipment, tooling and test methods.
• Ensure processes are capable, repeatable and suitable for sustained commercial production.

Quality, Regulatory & Risk Management

• Ensure engineering activities comply with applicable medical device regulations and quality standards, including ISO 13485, FDA requirements and EU MDR.
• Lead risk management activities in accordance with ISO 14971, including Design FMEA (DFMEA) and Process FMEA (PFMEA).
• Prepare, review and maintain technical documentation supporting design and manufacturing activities, including Design History Files (DHF) and Device Master Records (DMR).
• Work closely with Quality to maintain compliance, product safety and robust quality systems.

Project Management & Cross-Functional Collaboration

• Develop and maintain project plans, schedules, milestones and deliverables.
• Coordinate engineering activities to ensure projects progress efficiently and meet agreed timelines.
• Build strong working relationships across Engineering, Quality, Operations and external stakeholders.

What we are looking For

We are interested in an experienced, hands-on engineering professional who combines strong technical capability with leadership skills and a passion for innovation.

• A Bachelor's or Master's degree in Engineering, preferably Manufacturing, Mechanical, Electrical, Biomedical or Materials Science.
• At least 5 years' engineering experience within the medical device industry.
• Previous experience in a senior, lead or supervisory engineering role, with the ability to lead and develop a technical team.
• Strong knowledge of medical device regulations and quality standards, particularly ISO 13485 and FDA requirements.
• Demonstrable experience supporting the 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 experience with statistical analysis tools such as Minitab.
• Excellent communication and stakeholder management skills, with the ability to work effectively across multidisciplinary teams.

Why Consider This Opportunity?

This role offers the chance to:

• Take a leadership position within a growing and innovative medical device engineering environment.
• Make a real impact on the successful development and commercialisation of new products.
• Lead and develop a talented engineering team.
• Work at the intersection of R&D, process engineering and manufacturing.
• Influence manufacturing strategy, process capability and product quality.
• Contribute to products that ultimately make a difference to patients.