Design Assurance Engineer

Description We're looking for a Design Quality Assurance Engineer to join our growing Design QA team. In this role, you’ll collaborate closely with R&D, Engineering, and Manufacturing teams to support the design and development process and regulatory compliance. As we continuously evolve our product and processes toward PMA (Pre-Market Approval), this is a unique opportunity to join at a high-impact phase of development.

Responsibilities

Ensure that design and development activities are performed in accordance with applicable procedures and approved design and development plans. Work closely with project teams to provide quality and compliance input throughout the design and development process. Review and approve key design and development deliverables, including requirements, design outputs, and verification and validation documentation. Support Regulatory Affairs activities, including regulatory submissions, responses to regulatory questions, implementation of new or revised standards, and internal and external audits. Participate in project and design review meetings. Perform Design Quality activities within the product risk management process, including review and approval of DFMEA and related risk management documentation. Support and accompany Engineering Change Orders (ECOs), including assessment and completion of applicable quality activities. Provide Design Quality support for design transfer of new products and sustaining changes to Manufacturing, Operations Quality, and Supplier Quality.

Reports to QA Manager

Requirements

At least 3-5 years of experience working in a quality function in the medical device industry – must. At least 2-3 years of experience as a design control engineer (preferred). Prior hands-on experience in Verification & Validation (V&V) activities within the medical device industry – a significant advantage. A Bachelor of Science in Engineering, Sciences, or a related field – must. Experience with ISO 13485, ISO 14971, 21 CFR 820, EU MDR standards – must. Familiar with statistical techniques used in verification and validation processes (preferred). Strong analytical and problem-solving skills, with keen attention to detail. Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions. Strong execution and follow-up skills Ability to work in a fast-paced environment Proficient use of standard MS Office applications. Fluent in English (oral and written).