Mechanical R&D Engineer

HERO Recruitment Ltd.; Munster; On-site; EUR 55,000 - 75,000; Full time

Job summary

HERO Recruitment Ltd. in Clonmel, Co. Tipperary, seeks a Mechanical R&D Engineer to join a medical device R&D team. The role focuses on integration projects, providing mechanical engineering input and supporting design controls, risk management and regulatory activities.

You will collaborate with engineering, quality and manufacturing to ensure design activities meet quality and regulatory requirements, with emphasis on design verification, validation and documentation.

Qualifications

• Honours Bachelor's degree in Mechanical Engineering or related discipline.
• Experience in mechanical R&D within medical devices or regulated industry.
• Strong design controls and risk management experience.
• Experience supporting integration projects involving mechanical components.
• Understanding of design verification, validation and regulatory documentation.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Support mechanical R&D activities for product/system integration.
• Contribute to design controls throughout the engineering lifecycle.
• Support risk management identifying, assessing, mitigating design risks.
• Collaborate with cross-functional teams to resolve technical challenges.
• Evaluate and integrate mechanical components to meet design specs.
• Develop, review, and maintain engineering documentation.
• Develop and execute verification testing and methods.
• Investigate and resolve design/integration issues via root cause analysis.
• Ensure deliverables meet project timelines and quality standards.
• Maintain accurate technical documentation per quality systems and regulatory requirements.

Skills

Design controls

Risk management

Cross-functional collaboration

Analytical skills

Problem solving

Communication

Education

Bachelor's in Mechanical Engineering

Job description

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.