Research And Development Engineer

HERO Recruitment; Connacht; On-site; EUR 65,000 - 90,000; Full time

Job summary

HERO Recruitment is seeking an R&D Engineer II/III (Contractor) in Galway to drive catheter development, verification and design freeze activities within a regulated medical device environment.

You will independently own technical workstreams, collaborate across R&D, Quality, Regulatory, Manufacturing and Supply Chain, and contribute to test method development, documentation, and problem solving for catheter-based devices.

Qualifications

• Bachelor's degree in a relevant engineering field.
• 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 and Design Freeze activities.
• Experience developing and executing engineering test methods.

Responsibilities

• 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.
• 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.
• 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.
• 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.

Skills

Catheter design

Test method development

Root cause analysis

Documentation

Statistical analysis

Minitab

CAD (SolidWorks)

Education

Bachelor's Degree (Level 8) in Mechanical Engineering

Biomedical Engineering

Tools

SolidWorks

Minitab

Job description

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.
• 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 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.