Mechanical R&D Engineer.

The Role

HERO Recruitment is seeking a Mechanical R&D Engineer to join a medical device R&D team in Clonmel, Co. Tipperary.

The successful candidate will support an ongoing integration project, contributing mechanical engineering expertise and supporting design control, risk management and integration activities within a regulated medical device environment.

We are particularly interested in candidates with strong experience in mechanical R&D, design controls, risk management and the integration of products, components or systems. This opportunity would suit an engineer who can work effectively within a cross-functional team to support technical decision-making and ensure design activities meet quality, safety and regulatory requirements.

Key Responsibilities

• Support mechanical R&D activities associated with a product or system integration project.
• Contribute to design control activities throughout the engineering lifecycle, ensuring compliance with applicable medical device quality and regulatory requirements.
• Support risk management activities, including the identification, assessment, documentation and mitigation of design-related risks.
• Collaborate with cross-functional engineering, R&D, quality and manufacturing teams to support integration activities and resolve technical challenges.
• Support the evaluation and integration of mechanical components, assemblies or systems to ensure they meet defined design requirements and performance specifications.
• Assist with the development, review and maintenance of engineering documentation, including design inputs, outputs, verification activities and technical reports.
• Support the development and execution of verification testing and test methods to demonstrate that design requirements have been met.
• Identify, investigate and help resolve design and integration issues through structured problem-solving and root cause analysis.
• Ensure engineering deliverables are completed in line with project timelines, quality standards and applicable procedures.
• Maintain accurate technical documentation in accordance with relevant quality systems and regulatory requirements.

Education & Experience

• Honours Bachelor’s degree in Mechanical Engineering or a related engineering or technical discipline, or equivalent relevant experience.
• Previous mechanical R&D engineering experience within the medical device or another highly regulated industry.
• Strong experience with design controls and risk management within a regulated product development environment.
• Experience supporting integration projects involving mechanical components, assemblies, products or systems.
• Understanding of design verification, validation and associated technical documentation.
• Familiarity with medical device quality systems, design history documentation and applicable regulatory requirements.
• Strong analytical, problem-solving and organisational skills.
• Excellent communication skills, with the ability to collaborate effectively across multidisciplinary teams.