Senior R&D Engineer

Life Science Recruitment; Dublin; On-site; EUR 60,000 - 85,000; Full time

Job summary

A high potential start-up company in Dublin is seeking a Senior R&D Engineer to lead the design, development, and testing of medical devices. The role involves collaboration across multiple teams to ensure compliance with regulatory standards. Ideal candidates will have a degree in engineering or science and experience in the medical device industry. Strong project planning and communication skills are essential. This position offers the opportunity to work in a flexible and entrepreneurial environment.

Qualifications

• 3-5 years’ experience in medical device industry or 1-2 years plus a postgraduate qualification.
• Knowledge of medical device quality & regulatory systems (ISO13485, FDA CFR 820) is advantageous.

Responsibilities

• Design and develop medical devices in collaboration with regulatory teams.
• Conduct engineering testing and compile documentation per standards.
• Support CTO in product development through all phases.

Skills

Project planning skills

Excellent communication and writing skills

Mechanical design understanding

Knowledge of Solidworks/CAD

Medical device materials knowledge

Education

Degree in Engineering or Science

Tools

Solidworks

Job description

Our client a high potential start-up company are currently seeking a Senior R&D Engineer to join their team. The Senior R&D Engineer will be responsible for the design, development and testing of medical devices. The role will involve working with Engineering, Quality and Regulatory teams to ensure devices meet user need requirements, regulatory requirements and that activities are completed in compliance to ISO 13485 and 21 CFR 820 requirements. The candidate will report to the Chief Technical Officer (CTO) and work across all stages of device development, from prototyping, final manufacture, clinical investigation and commercialisation. A hands-on approach to projects with a good attitude and work ethic is essential, with an ability to work in a cross functional, flexible and small entrepreneurial environment.





Role/Responsibilities:

• Work closely with clinicians, quality, regulatory and clinical to develop innovative medical devices
• Support the CTO in current product development and pipeline products, through all aspects of the product development process
• Ensure all work is carried out in compliance with Quality, Regulatory and company policies and systems.
• Assess new product concepts through technical analyses of competitor products, literature reviews, IP landscape and working with regulatory to establish route to market
• Participate in the creation and maintenance of product Risk Management Files.
• Select materials, components and equipment based on analysis of specifications, reliability and regulatory requirements.
• Participate in the control of manufacture of components and the assembly of devices for the purposes of design verification testing and clinical evaluation.
• Conduct engineering bench testing, CAD, prototyping, write technical aspects of patents, Finite element analysis.
• Compile documentation to support product development in accordance with the Medical Device Directive (MDD) andProVerum’s ISO 13485 Quality Management System - complete tasks including document control and writing protocols and test reports.
• He / She will be required to meet with European and U.S. contractors / suppliers on an as needs basis.

Our client a high potential start-up company are currently seeking a Senior R&D Engineer to join their team. The Senior R&D Engineer will be responsible for the design, development and testing of medical devices. The role will involve working with Engineering, Quality and Regulatory teams to ensure devices meet user need requirements, regulatory requirements and that activities are completed in compliance to ISO 13485 and 21 CFR 820 requirements. The candidate will report to the Chief Technical Officer (CTO) and work across all stages of device development, from prototyping, final manufacture, clinical investigation and commercialisation. A hands-on approach to projects with a good attitude and work ethic is essential, with an ability to work in a cross functional, flexible and small entrepreneurial environment.





Role/Responsibilities:

• Work closely with clinicians, quality, regulatory and clinical to develop innovative medical devices
• Support the CTO in current product development and pipeline products, through all aspects of the product development process
• Ensure all work is carried out in compliance with Quality, Regulatory and company policies and systems.
• Assess new product concepts through technical analyses of competitor products, literature reviews, IP landscape and working with regulatory to establish route to market
• Participate in the creation and maintenance of product Risk Management Files.
• Select materials, components and equipment based on analysis of specifications, reliability and regulatory requirements.
• Participate in the control of manufacture of components and the assembly of devices for the purposes of design verification testing and clinical evaluation.
• Conduct engineering bench testing, CAD, prototyping, write technical aspects of patents, Finite element analysis.
• Compile documentation to support product development in accordance with the Medical Device Directive (MDD) andProVerum’s ISO 13485 Quality Management System - complete tasks including document control and writing protocols and test reports.
• He / She will be required to meet with European and U.S. contractors / suppliers on an as needs basis.

Skills/Experience:

• The successful candidate should be degree qualified in a relevant Engineering or Science discipline and have the following skills and experience.
• 3-5 years’ experience in medical device industry or 1-2 year’s experience in combination with a postgraduate qualification (masters or PhD)
• Project planning skills
• Excellent communication and writing skills
• Good mechanical design and understanding of engineering fundamentals with extensive medical device materials knowledge.
• Good working knowledge of Solidworks or other CAD package
• Knowledge of FEA an advantage
• Knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820) would be a distinct advantage