Design Assurance Engineer

About the Role

We are looking for a proactive Design Assurance Engineer to contribute to both the maintenance of existing medical device products and the advancement of new developments. This role encompass supporting software and electronics-based medical device systems across their full lifecycle. The engineer will ensure rigorous application of design controls, risk management, verification, validation, and compliance with regulatory requirements.

Key Responsibilities

• Provide support for sustaining and new product initiatives from a Design Assurance standpoint during all product lifecycle phases.
• Ensure adherence to relevant design control, risk management, and quality system standards, including FDA and international medical device regulations.
• Evaluate design changes considering quality, risk, usability, biocompatibility, manufacturing, software, electronics, and regulatory impacts.
• Plan and conduct design verification and validation, including preparing protocols, reports, and traceability documentation.
• Lead risk management by identifying, assessing, controlling, and maintaining risks per FDA, ISO 14971, and ISO 13485 standards.
• Create and maintain Design History Files and other design documentation records.
• Organize and document design reviews to ensure compliance and project milestone progression.
• Work collaboratively with R&D teams on mechanical, software, and electronics aspects to apply design assurance principles effectively.
• Oversee complaint investigations and post-market surveillance, performing technical and root cause analyses, supporting CAPA development and effectiveness assessments.
• Contribute design assurance insights during manufacturing, supplier, and process change initiatives.
• Support regulatory submissions, audits, and inspections through technical documentation and expertise.
• Engage in continuous improvement of design assurance, quality, and product development processes.
• Mentor junior engineering staff as required.

Education and Experience

• Bachelor's degree (NFQ Level 8 or equivalent) in Engineering, Biomedical Engineering, Science, Software or Electronics Engineering, or related technical field.
• Minimum of three years experience in Design Assurance or related medical device industry role.
• Strong familiarity with medical device regulatory standards and quality system requirements such as ISO 13485, ISO 14971, and FDA QMSR (21 CFR Part 820).
• Working knowledge of IEC 62304, IEC 60601, and ISO 62366 standards, especially as applied to software, electronics, and medical device projects.
• Experience in design control activities, risk management, and product verification/validation.
• Preferential experience with software and electronics development projects, complaint investigations, CAPA, and post-market support.
• Excellent technical writing, analytical, organizational, and communication capabilities.
• Capability to work independently and collaboratively within cross-functional teams and manage multiple tasks effectively.

Key Competencies

• Strong problem-solving and analytical abilities.
• Effective communication and teamwork skills.
• Independent working aptitude combined with team collaboration.
• Decision-making grounded on risk-based thinking.
• Commitment to continuous improvement initiatives.
• Ability to foster strong cross-functional relationships within the organization.
• Detail-oriented with a strong focus on quality.

Additional Information

This role is ideal for a professional with foundational medical device engineering experience seeking to deepen expertise across product sustaining activities while contributing to innovative medical technology development.