DESCRIPTION: My client is seeking a motivated Design Assurance Engineer to support both commercially released products and ongoing product development activities. This role will work across sustaining engineering projects and new product development initiatives, including support for software and electronics-based medical device systems.

The successful candidate will be responsible for ensuring that design control, risk management, verification and validation, and regulatory requirements are effectively applied throughout the product lifecycle.

Working closely with R&D, Manufacturing Engineering, Quality, and Regulatory Affairs, the Design Assurance

Engineer will support product changes, development activities, compliance initiatives, and continuous improvement of design assurance processes.

KEY RESPONSIBILITIES:

• Support sustaining and new product development projects from a Design Assurance perspective throughout the product lifecycle.
• Ensure compliance with applicable design control, risk management, and quality system requirements, including FDA and international medical device standards.
• Contribute to design change activities, including assessment of quality, risk, usability, biocompatibility, manufacturing, software, electronics, and regulatory impacts where applicable.
• Plan, execute, and document design verification and validation activities, including generation of protocols, reports, and traceability documentation.
• Lead risk management activities, ensuring risks are identified, evaluated, controlled, and maintained throughout the product lifecycle to meet FDA, ISO 14971, and ISO 13485 requirements.
• Generate and maintain Design History Files (DHF) and other design and development records.
• Plan, prepare, facilitate, and document design reviews, ensuring compliance with design control requirements and effective progression through project milestones.
• Collaborate with R&D teams supporting mechanical, software, and electronics development activities, ensuring appropriate application of design assurance principles
• Lead complaint investigations and post-market surveillance activities, conducting technical assessments and root cause analysis, and support CAPA development, implementation, and effectiveness reviews.
• Provide design assurance input to manufacturing, supplier, and process change activities.
• Assist in regulatory submissions, audits, and inspections by providing supporting documentation and technical expertise.
• Contribute to continuous improvement initiatives within Design Assurance, Quality, and Product Development processes
• Mentor junior engineers as needed.

EDUCATION & EXPERIENCE

• Bachelor's degree (Level 8 NFQ or equivalent) in Engineering, Biomedical Engineering, Science, Software Engineering, Electronics Engineering, or a related technical discipline
• Approximately 3+ years of experience in Design Assurance, or a related role within the medical device industry.
• Strong knowledge of medical device regulations and standards, including:
• ISO 13485
• ISO 14971
• FDA Quality Management System Regulation (QMSR; 21 CFR Part 820)
• Working knowledge of IEC 62304, IEC 60601, and ISO 62366 and their application within software, electronics, and medical device development projects.
• Experience supporting design control activities, risk management, and product verification and validation.
• Exposure to software and electronics development projects is desirable.
• Experience with complaint investigations, CAPA activities, or post-market product support is advantageous.
• Strong technical writing, analytical, organisational, and communication skills.
• Ability to work effectively as part of cross-functional teams while managing multiple priorities.

KEY COMPETENCIES

• Problem-solving and analytical thinking
• Effective communication and collaboration skills
• Ability to work independently and as part of a team
• Decision-making supported by risk-based thinking
• Continuous improvement mindset
• Ability to build strong cross-functional relationships across the organisation
• Strong attention to detail and quality mindset