Quality Assurance Engineer – Medical Device Hardware & Software Design Controls

We are seeking a Quality Assurance Engineer with experience or expertise in medical device hardware and software design controls to support the implementation and continuous improvement of our Quality Management System (QMS) and the application of design control processes throughout product development.

The role will work closely with OnaWave's engineering and regulatory teams to ensure that both hardware and software development activities are appropriately planned, documented, reviewed, verified and controlled within the company's quality management framework.

Typical activities include:

• Supporting the implementation and maintenance of the Company's ISO 13485 Quality Management System.
• Supporting hardware and software design control activities throughout the medical device development lifecycle.
• Ensuring appropriate definition and traceability of design inputs, design outputs, verification activities and design changes.
• Preparing and maintaining Design History File (DHF) documentation.
• Supporting risk management activities in accordance with ISO 14971 and ensuring appropriate linkage between risk management and hardware/software development.
• Supporting hardware and software verification and validation planning and documentation.
• Supporting software lifecycle documentation and its integration with the overall medical device design control process.
• Supporting document control, configuration management and engineering change control processes.
• Assisting with supplier quality documentation and controls relating to externally supplied components and development activities.
• Supporting preparation of technical documentation for regulatory submissions.
• Participating in design reviews and cross-functional engineering meetings.
• Identifying opportunities to improve and standardise design control processes across the hardware and software development teams.

The successful candidate will gain direct experience working within a regulated medical device environment and will make a practical contribution to the quality and design control documentation supporting OnaWave's future clinical and regulatory activities.

We are particularly interested in candidates with a background in one or more of the following areas:

• Medical Device Engineering
• Quality Engineering
• Biomedical Engineering
• Software Engineering
• Electronic Engineering
• Systems Engineering
• Mechanical Engineering
• Regulatory Affairs

Candidates should ideally have knowledge or practical experience of design controls for medical devices incorporating both hardware and software.

Experience or knowledge in some of the following would be particularly advantageous:

• ISO 13485 quality management systems.
• Medical device design controls.
• Hardware development within a regulated design control framework.
• Medical device software development and software lifecycle processes.
• Design inputs, outputs, reviews, verification, validation and design transfer.
• Requirements management and design traceability.
• ISO 14971 medical device risk management.
• IEC 62304 medical device software lifecycle processes.
• IEC 60601 or related standards for medical electrical equipment.
• EU Medical Device Regulation (MDR).
• Design History File and technical documentation preparation.
• Configuration management and engineering change control.

Candidates should also have strong attention to detail, excellent written communication and documentation skills, good organisational skills, and the ability to work independently while collaborating effectively with a multidisciplinary engineering and regulatory team.

• Duration: 3-6 months (flexible)
• Location: Remote, with optional visits to Ireland
• Start Date: Flexible