The Design Assurance Engineer role will be instrumental in shaping the NPI Project deliverables to support our ID new product development pipeline and sustaining our existing on-market product portfolio. They will provide direction to and ensure compliance across all our Core Teams and Extended Teams – R&D, Marketing, QA, RA, Clinical Operations and Operations.

 Essential Duties and Responsibilities

• Carries out duties in compliance with established business policies and procedures.
• Demonstrates commitment to the development, implementation, and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.
• Responsible for exhibiting professional behaviour with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.
• Possesses and applies a broad and increasing knowledge of Quality, and its application
• Promotes the awareness of regulatory and customer requirements throughout the organization.
• Supporting the remediation of current labelling procedures, alignment to IVDR Labelling requirements and practices across sites and to standardise to “best in class” labelling practices for the ID BU. Liaise with Design Assurance, R&D, quality systems and regulatory affairs personnel within the Business Unit to ensure team’s compliance and to drive alignment and harmonization.
• Update and create documents as required through the change control process.
• Perform technical reviews of product labelling, support design reviews and product updates.
• Support existing On-Market ID products, ensure rigorous impact assessments are performed on all labelling design changes, appropriate verification/validation activities are executed, and Design History Files are maintained. 
• Escalate where appropriate design control concerns/ issues in a timely manner to ensure project schedule maintenance.
• Provision of on-going risk management, design control, quality systems and overall design assurance expertise and leadership to the Project Core and Extended teams.
• Participate in and support for audits including our clients Audits and external Regulatory/ Governing Body audits (e.g. IVDR, FDA, WHO). 
• Perform other duties and projects as assigned.
• Travel pending company policy, global and country regulations.

Education / Experience / Skills

• Primary Degree level qualification in Science, Engineering or Technology, plus 2-3 years of Quality Engineering/ Design Assurance work experience within a regulated environment (ISO13485/ FDA).
• Formal training in Medical Device Risk Management, Process Validation, Software Validation and problem solving would be beneficial.
• Excellent data analysis skills.
• Proven ability to work well as part of a team and on their own.
• Excellent communication skills to support virtual project requirements.
• Clear demonstrated experience in working in a diverse cultural environment.
• Excellent presentation skills to facilitate communication throughout the organisation. 

For more information and a confidential discussion on the role please contact Chris O Toole