Research & Development Engineer II

Key Responsibilities:

• Oversee design development, prototyping, test method creation, design evaluation, design reviews, and design specifications. Conduct design verification and validation, create design protocols and reports, and manage transfer to production activities efficiently.
• Perform product testing and evaluation, and complete test reports to support design selection.
• Prepare and present design reviews to stakeholders.
• Conduct product and project risk analysis and implement risk management strategies.
• Collaborate with Process Development Engineering to introduce or develop new equipment and production processes for new manufacturing techniques.
• Identify and source new materials, components, and equipment.
• Develop component specifications, inspection methods, bills of materials, and manufacturing processes.
• Introduce new equipment, materials, and technologies into production.
• Work closely with Key Opinion Leaders (KOLs), physicians, and product managers to develop innovative medical devices that enhance patient care.
• Lead assigned research and development projects, managing both technical and project management aspects.
• Ensure compliance with quality, regulatory, and company policies and systems.
• Maintain regular communication with cross-functional teams, senior management, and business unit leaders. Provide updates on project status and reporting.

Qualifications:

• Bachelor’s degree in Engineering or a related field.
• Minimum of 3 years of relevant experience.
• Demonstrated project planning skills with the ability to execute projects efficiently and effectively.
• Strong mechanical design skills and understanding of engineering fundamentals, with extensive knowledge of medical device materials.
• Understanding of manufacturing design and processes.
• Proficiency in SolidWorks and/or Pro Engineer CAD software.
• Strong technical writing skills.
• Knowledge of medical device quality and regulatory systems, including ISO 13485, FDA CFR 820, and EU Medical Device Regulation 2017/745.
• Willingness and availability to travel for company business

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

For further information on this please contact Johanne Kennedy on 0864403725 / choices@hero.ie Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.