Senior R&D Engineer 

Role Summary

CREGG are hiring for a Senior / Principal R&D Engineer to join a Medical Device company in Galway. Immediate start required.

The R&D Engineer will lead and support the development of innovative medical device systems, with primary responsibility across pump head characterisation, distal tip development, packaging design, verification testing, and supplier management activities. The role requires strong technical problem-solving capability, hands-on development experience, and the ability to drive design decisions through robust testing and data analysis within a regulated medical device environment.

Key Responsibilities

 Pump Head System Characterisation

• Characterise pump head system elements including balloon, valves, and vent length.
• Identify and optimise key parameters influencing system flow performance while minimising cup/braid deflection.
• Design and execute experimental studies to evaluate fluidic and mechanical performance.
• Analyse, interpret, and present data to support engineering and design decisions.
• Collaborate cross-functionally to implement performance improvements and design optimisations.

Required Skills & Experience

• Strong understanding of fluid mechanics and flow systems.
• Experience in test design, execution, and statistical interrogation of results.
• Ability to communicate technical findings clearly to support decision-making.

 Distal Tip Development

• Lead the design and development of distal tip components from concept through verification.
• Generate and manage design requirements, ideation activities, prototyping, and process development.
• Coordinate verification testing and ensure design outputs meet performance and usability requirements.
• Select appropriate materials and joining methods for catheter-based systems.
• Support design reviews and documentation activities in compliance with quality system requirements.

Required Skills & Experience

• Proficiency in CAD and PDM systems.
• Experience in materials selection and joining processes for medical devices.
• Hands-on prototyping and product development experience.

 Verification & Challenge Testing

• Lead challenge testing activities including performance evaluation and bond integrity assessment following ageing and simulated sterilisation conditions.
• Develop, validate, review, and approve test methods and protocols.
• Ensure testing activities are executed in accordance with applicable quality and regulatory standards.
• Prepare technical reports and documentation for design verification and regulatory submissions.

Required Skills & Experience

• Experience developing and executing verification and validation test methods.
• Strong analytical and problem-solving capability.
• Experience with documentation review and approval within a Quality Management System (QMS).
• Ability to present technical conclusions and recommendations based on data.

 Packaging Development

• Lead the design and procurement of packaging components including trays, backing cards, pouches, cartons, and shippers for the Flow Catheter System.
• Develop packaging solutions supporting sterilisation, transportation, and usability requirements.
• Collaborate with suppliers and manufacturing partners to optimise packaging performance and manufacturability.
• Support packaging verification and validation activities.

Required Skills & Experience

• Proficiency in CAD/PDM systems.
• Experience designing for thermoforming processes.
• Knowledge of EO sterilisation processes and packaging compatibility requirements.
• Understanding of transport testing and usability considerations.

 Supplier & External Development Management

• Manage external development activities
• Provide technical direction and oversight to external partners and suppliers.
• Develop and execute verification testing strategies for outsourced components.
• Ensure supplier deliverables meet project timelines, quality requirements, and technical specifications.

Required Skills & Experience

• Experience managing supplier interactions and technical development activities.
• Ability to define and execute verification testing plans.
• Strong communication and stakeholder management skills.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Materials Engineering, or related discipline.
• 3–7+ years’ experience in medical device R&D or product development preferred.
• Experience working within a regulated medical device environment (ISO 13485/FDA).
• Catheter or minimally invasive device experience desirable.

INDTRAC