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).