R&D Engineer (Medical Devices)
Location: Athlone, Ireland
Department: Manufacturing / R&D
Reporting to: Head of Operations
Start Date: Q3
We are partnering with an innovative medical device company to recruit an R&D Engineer for their new manufacturing facility in Athlone. This is an exciting opportunity to join a growing start-up environment and play a key role in the design and development of electrode-based medical technologies.
The successful candidate will support the full product development lifecycle, from concept and prototyping through to validation and transfer to manufacturing, while ensuring compliance with regulatory and quality standards. This role will also support on-site laboratory testing activities and collaborate closely with customers, suppliers, and internal stakeholders.
Key Responsibilities:
Product Development & Design- Support the design and development of electrodes within the product development lifecycle
- Generate and maintain required design and development documentation throughout all project phases
- Lead preparation and review of technical reports and product development documentation
- Apply relevant regulatory and safety requirements to all product and project activities
- Support prototype development, testing, and evaluation activities
- Utilise CAD tools to support design activities and prototype generation
- Manage multiple development projects and priorities simultaneously
Testing, Validation & Laboratory Activities
- Lead on-site test laboratory activities, including:
- Accelerated ageing studies
- IEC 60601 electrical safety testing
- Product and process validation activities
- Identify, specify, and implement appropriate testing methodologies and validation protocols
- Lead equipment validation activities (IQ/OQ/PQ)
- Manage product development testing schedules and timelines
- Support investigation of process or product-related issues using structured problem-solving techniques
Manufacturing & Technical Transfer
- Provide engineering support to manufacturing during product transfer and process validation activities
- Support technical transfer and start-up activities as required
- Collaborate with manufacturing and operations teams to ensure successful process implementation
- Contribute to continuous improvement initiatives across product and process development
Regulatory & Quality Compliance
- Ensure compliance with FDA 21 CFR Part 820 and ISO 13485 requirements
- Work within a regulated quality management system environment
- Support documentation control, change management, and validation activities
- Ensure all development activities are completed in accordance with company procedures and regulatory expectations
Collaboration & Stakeholder Management
- Liaise directly with customers, suppliers, and internal stakeholders
- Monitor, record, and report project progress in line with company standards
- Stay up to date with emerging materials, technologies, and industry developments to support innovative product solutions
- Contribute positively within a fast-paced start-up environment requiring flexibility and adaptability
Requirements:
- Bachelor’s degree in Engineering (Electrical, Biomedical, Mechanical, or related discipline)
- 2–5+ years’ experience in an R&D or product development environment
- Understanding of the product development lifecycle process
- Experience within a regulated manufacturing or medical device environment is desirable
- Exposure to technical transfer, process development, or start-up activities is advantageous
- Experience with validation activities (IQ/OQ/PQ)
- Strong communication and cross-functional collaboration skills
- Ability to work independently and as part of a team with minimal supervision
- Strong problem-solving and decision-making capability
- Ability to manage multiple projects within a fast-paced environment
- Proficiency in CAD and prototype development
For more information or to apply, please contact: Aoife Regan
Email: aoife.regan@collinsmcnicholas.ie
Phone: (090) 6450 760
