Design Assurance Engineer II – Join a Leading Medical Device Innovator in County Galway, Ireland 

Are you a skilled Design Assurance Engineer looking to make a real impact in the medical device industry? We are working with a prestigious company based in County Galway, Ireland, and currently seeking a highly motivated Design Assurance Engineer II to join their dynamic team. This is an exciting permanent opportunity for an experienced professional to contribute to the development of innovative, life-saving products. If you are passionate about quality assurance and compliance in medical device engineering, this could be the perfect role for you. 

 

Role Overview: 

The Design Assurance Engineer II will play a pivotal role in ensuring the highest quality standards are maintained throughout the product development lifecycle. This position will be responsible for ensuring compliance with regulatory standards, risk management, and promoting a culture of continuous improvement in product development processes. By collaborating with cross-functional teams, you will help deliver cutting-edge medical devices that improve patient safety and quality of life. 

 

Key Responsibilities: 

• Collaborative Project Support: Work closely with R&D, Regulatory Affairs, Clinical, Marketing, Process Development, and Manufacturing teams to drive the development of innovative medical devices. 

• Regulatory Compliance: Interpret and fulfil regulatory requirements, ensuring compliance with internal and external standards, including ISO, EN, FDA, and MDD regulations. 

• Quality Assurance Leadership: Monitor and update quality policies to align with product development needs. Continually seek opportunities to drive improvements in product and process quality. 

• Documentation Control: Implement, maintain, and update procedures to ensure that R&D documentation meets product development and design control requirements. 

• Independent Review: Conduct quality reviews at key stages of the design process, including design reviews, risk management, and design verification/validation for both new product developments and design/process changes. 

• Audit Support: Assist in internal and external audits, ensuring the highest standards of regulatory compliance and process excellence. 

 

Technical Expertise Required: 

• Regulatory and Compliance Expertise: In-depth knowledge of design control, risk management, verification, validation, and the regulatory landscape. 

• Risk Management and Analysis: Ability to summarise, analyse, and draw conclusions from test results and other process-related findings, ensuring well-informed decisions. 

• Verification and Validation: Proficiency in verification/validation techniques, statistical analysis, and understanding regulatory requirements in medical device development. 

• Standards Compliance: Strong understanding of ISO/EN/FDA/MDD regulations, keeping up to date with the latest developments in the medical device sector. 

• NCEP Process Knowledge: Familiarity with the New Product Introduction (NCEP) process is an advantage. 

 

Education & Experience: 

• Bachelor’s Degree in a relevant STEM field such as Quality, Science, or Engineering. 

• A minimum of 3 years' experience in a similar role. 

 

Why Join This Team? 

• Work with an innovative company at the forefront of medical device development, making a tangible impact on patient safety and quality of life. 

• Enjoy a supportive team environment, offering opportunities for growth, learning, and continuous improvement. 

• Be part of a company committed to quality and excellence in everything they do, where your expertise will be valued and your career will thrive. 

 

“Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters 

 

For further information on this role please contact Lisa Lawlor on 08683955 or email stem@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.”