Process Engineer (Medical Devices / Technical Transfer)
Location: Athlone, Ireland
Department: Manufacturing / R&D
Reporting to: Head of Operations
Start Date: Q2
We are partnering with an innovative medical device company to recruit a Process Engineer for their new manufacturing facility in Athlone. This is a key role supporting site start-up activities, including the transfer of manufacturing processes from an existing site and the development of robust, scalable production operations.
We are open to candidates from medical device or electronics manufacturing environments with relevant process engineering experience.
The successful candidate will play a critical role in process development, validation, and continuous improvement while ensuring compliance with regulatory and quality standards.
Key Responsibilities:
Start-Up & Technical Transfer
- Support the transfer of manufacturing processes to the new Athlone facility
- Assist in developing and executing technical transfer plans, including timelines, risk assessments, and resource requirements
- Collaborate with cross-functional teams to ensure successful process replication and scale-up
- Support site start-up activities, including line setup, commissioning, and initial production runs
Process Development & Implementation
- Develop, document, and implement manufacturing processes and work instructions
- Identify and control critical process parameters (CPPs)
- Troubleshoot process issues during ramp-up and early production phases
- Drive continuous improvement in yield, efficiency, and process robustness
Validation & Compliance
- Lead and execute process and equipment validation activities (IQ/OQ/PQ)
- Ensure compliance with FDA 21 CFR Part 820 and ISO 13485
- Prepare and review validation documentation and technical reports
Cleanroom Manufacturing
- Work within a cleanroom/white room environment
- Adhere to gowning and contamination control procedures
- Support monitoring and improvement of environmental controls
Test Lab & Product Verification
- Support on-site test laboratory activities, including:
- Product testing and inspection (e.g. accelerated ageing, IEC 60601 electrical safety testing)
- Process validation and verification
- Investigation of process or product issues
- Use test data to inform process improvements and ensure product performance
Documentation & Quality Systems
- Develop and maintain:
- Standard Operating Procedures (SOPs)
- Work instructions and manufacturing records
- Process flow diagrams and control documentation
- Support CAPA, non-conformance investigations, and change control activities
Equipment & Facility Support
- Assist with installation, commissioning, and qualification of manufacturing equipment
- Support manufacturing layout and workflow design
- Liaise with equipment vendors and internal stakeholders
Requirements:
- Bachelor’s degree in Engineering (Electrical, Biomedical, Mechanical, or related discipline)
- 3–5+ years’ experience in a regulated manufacturing environment (medical devices preferred)
- Experience in cleanroom/controlled environments is desirable
- Exposure to technical transfer, process development, or site start-up activities is an advantage
- Strong communication and cross-functional collaboration skills
- Ability to work independently and within a team in a fast-paced environment
- Strong problem-solving and decision-making capability
Technical Skills Required:
- Process validation (IQ/OQ/PQ)
- Good Manufacturing Practices (GMP)
- Root cause analysis and structured problem-solving tools
- Familiarity with statistical methods and process capability analysis (advantageous)
- Experience supporting new product introduction (NPI) or site start-ups
- Exposure to test methods/lab environments (e.g. IEC 60601, accelerated ageing) is beneficial
For more information or to apply, please contact: Aoife Regan
Email: aoife.regan@collinsmcnicholas.ie
Phone: (090) 6450 760
