We are seeking a Design Quality Engineer (DQE) to support R&D teams in transitioning from non-medical to medical device development. This role is critical in ensuring compliance with medical device regulations (ISO 13485, 510K, IEC 62304, risk management, usability, clinical evaluation) for key projects. Reporting to the PMO Lead, you will play a key role in technical file development, regulatory alignment, and cross-functional facilitation.
Key Responsibilities
* Develop and maintain technical files for medical device projects.
* Collaborate with project managers, software architects, security teams, and usability engineers.
* Act as a liaison between R&D and QARA teams, ensuring regulatory clarity.
* Coach and mentor teams on best practices in IEC 62304 and related standards.
* Identify gaps in compliance processes and drive improvements.
* Support audits by ensuring documentation is complete and audit-ready.
* Develop training programs to enhance R&D's regulatory knowledge.
Required Qualifications
* Proven experience in developing technical files for medical devices.
* Strong knowledge of ISO 13485, 510K, IEC 62304, and risk management.
* Excellent communication and facilitation skills for cross-functional collaboration.
* Ability to coach and mentor teams to improve compliance and documentation quality.
* Strong problem-solving and analytical skills to identify and address process gaps.
* Attention to detail to ensure accuracy in technical documentation.
Why Join Us?
* Be part of an impactful R&D team working on cutting-edge medical devices.
* Work in a dynamic cross-functional environment with technical experts.
* Opportunity to drive quality and compliance in medical device innovation.
Apply now to contribute to the future of medical technology