R&D Engineer II / III (Contractor) and Senior R&D Engineering Roles
Galway
The successful candidate will apply strong catheter engineering fundamentals to support design freeze activities, test method development, design verification execution, technical investigations, and documentation required within a regulated medical device development environment.
This role requires an engineer who is comfortable independently driving technical workstreams, taking ownership, while collaborating effectively across R&D, Quality, Regulatory, Manufacturing, and Supply Chain functions.
The engineer will contribute across design, testing, technical problem solving, documentation, and development activities while collaborating closely with PD/Manufacturing, Design assurance, Regulatory, Clinical and Supplier teams.
Key Responsibilities
Product Development & Technical Execution
- Support design refinement and development activities for a delivery system through design freeze and design verification.
- Execute engineering activities related to catheter design, component selection, materials evaluation and design changes.
- Develop, execute, and document engineering studies to characterize product performance.
- Design, develop, and validate test methods to support product verification activities.
- Author protocols, reports, engineering assessments, specifications and technical documentation.
- Analyze test data and provide clear technical conclusions and recommendations.
- Support risk management activities, design reviews, and technical assessments.
Catheter Engineering
- Contribute technical expertise in catheter design, materials, and manufacturing processes.
- Support development and optimization of bonded catheter assemblies including adhesive selection, bond development, and bond characterization.
- Lead troubleshooting and root cause investigations related to catheter performance, materials, manufacturing processes, and product reliability.
- Develop and execute mechanical testing including tensile, bond strength, flexibility, torque, trackability, durability, and related catheter characterization methods.
- Collaborate with suppliers and manufacturing teams to resolve technical challenges and improve process robustness.
Verification & Problem Solving
- Plan and execute verification testing activities in accordance with project timelines.
- Participate in test method validation and equipment qualification activities.
- Apply structured engineering problem-solving techniques and statistical methods to investigate issues and drive robust solutions.
- Support design change assessments and associated verification activities.
- Drive issues to closure through data-driven decision making.
Cross-Functional Collaboration
- Work effectively within cross-functional project teams including R&D, PD, DA, Manufacturing, Regulatory Affairs, Clinical Affairs, and Supply Chain.
- Present technical work and recommendations to project teams and leadership.
- Support / Mentor junior engineers and technicians where appropriate.
- Demonstrate ownership of deliverables and the ability to work independently with minimal supervision.
Required Qualifications
- Bachelor's Degree (Level 8) in Mechanical Engineering, Biomedical Engineering, Materials Engineering, or related discipline.
- Minimum 3 years medical device product development experience.
- Preferred 5+ years’ experience developing catheter-based medical devices.
- Must have Experience supporting products through Design Verification (DV) and Design Freeze activities.
- Experience developing and executing engineering test methods.
- Strong technical report writing and documentation skills.
- Experience operating within a regulated medical device environment.
- Demonstrated problem-solving and root cause investigation capabilities.
Preferred Experience
- Catheter design and development.
- Catheter materials selection and characterization.
- Bond development, adhesive selection, and bond testing.
- Design verification planning and execution.
- Statistical analysis and Design of Experiments (DOE).
- Supplier technical collaboration and issue resolution.
- Manufacturing process development and scale-up support.
- Design control and risk management activities.
Technical Skills
- Mechanical and catheter-based device design.
- Test method development and validation.
- Verification testing and report generation.
- Root Cause Analysis and structured problem solving.
- Statistical analysis using Minitab.
- CAD design and drawing creation using SolidWorks.
- Technical communication and presentation skills.
Leadership & Behaviours
- Strong engineering fundamentals and sound technical judgement.
- Self-starter capable of identifying problems and driving solutions with limited supervision.
- Demonstrates strong engineering judgement and technical decision-making.
- Comfortable presenting technical information to project teams and leadership.
- Builds effective working relationships across multiple functions.
- Provides technical mentorship and guidance to less experienced engineers.
- Demonstrates curiosity, ownership, accountability, and a continuous improvement mindset.
- Uses sound engineering principles and data-driven decision making to guide technical recommendations.
