Senior R&D Engineer

Location: Galway, Ireland

The Opportunity

A growing international medical device organisation is seeking an experienced Senior R&D Engineer to support the design, development, prototyping, testing and transfer of innovative medical device projects. This role is suited to an engineer who can provide strong technical expertise, practical problem-solving skills and hands-on engineering support across multiple development programmes.
The successful candidate will help translate customer, clinical and technical requirements into practical device concepts, prototypes, test plans, manufacturing documentation and design outputs. The role requires close collaboration with design, quality, manufacturing, supply chain and commercial teams to deliver safe, effective and manufacturable products.

Key Responsibilities

R&D Project Delivery: Support the planning and execution of R&D projects including concept development, feasibility studies, prototype builds, design iterations, verification testing and design transfer activities.
Design & Development: Develop and refine medical device concepts in line with customer requirements, user needs, regulatory expectations and manufacturability considerations.
Prototyping & Testing: Build, coordinate and evaluate prototypes, develop test methods, support laboratory testing, analyse results and recommend design improvements.
Technical Documentation: Prepare and maintain technical documentation including design inputs/outputs, drawings, BOMs, manufacturing procedures, test protocols, reports, risk assessments and technical summaries.
Cross-Functional Collaboration: Work closely with quality, manufacturing, procurement, commercial and customer-facing teams to ensure project objectives are achieved.
Supplier Support: Assist with supplier communication, component sourcing, material selection and evaluation of purchased components.
Quality & Compliance: Support compliance with ISO 13485-aligned quality systems, design controls, risk management processes, documentation control and audit readiness.
Problem Solving: Identify technical challenges, perform root cause investigations and support structured problem-solving activities.
Communication: Provide clear technical updates, participate in stakeholder meetings and communicate project risks and progress effectively.

Skills & Experience

• Bachelor's degree in Mechanical, Biomedical, Materials, Polymer, Electrical or related Engineering discipline.
• Typically 5-8 years of relevant engineering experience within medical devices, life sciences or regulated manufacturing environments.
• Experience in medical device development, prototyping, testing, design transfer, manufacturing processes or component development.
• Exposure to catheter-based, minimally invasive, vascular, drug delivery or cleanroom-manufactured devices would be advantageous.
• Working knowledge of ISO 13485, design controls, risk management, verification testing, documentation control and change control.
• Ability to interpret engineering drawings, specifications, test data and manufacturing procedures.
• Experience with CAD, prototyping, test method development, process development or statistical analysis would be beneficial.
• Strong project execution skills with the ability to manage priorities and meet deadlines.
• Excellent written and verbal communication skills.
• Collaborative approach with strong ownership, curiosity and practical engineering mindset.

Personal Attributes

The successful candidate will be a practical, solutions-focused engineer who thrives in a dynamic project environment. They will demonstrate strong attention to detail, sound technical judgement and the ability to balance innovation, compliance and manufacturability.

Package & Benefits

• Competitive salary and bonus package
• Occupational pension scheme
• Health and life assurance benefits
• Professional development and career progression opportunities
• Collaborative and innovative working environment

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