Design Assurance Engineer

About the Company

Magenta Medical is a Class III medical device company developing the world’s smallest heart pump, meant to provide minimally invasive support to the heart during acute episodes of dysfunction. The Elevate™ System is multi-disciplinary, involving mechanical engineering, materials science, electrical engineering, software, algorithms, and state-of-the-art catheter fabrication techniques. As we approach commercial manufacturing and scale-up, we're expanding our Operations, Engineering, Clinical Support, R&D, and Marketing teams. We are looking for the best people possible who can help us advance the Elevate™ System to the market and help us save more lives

About the Role

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.

Qualifications

• A Bachelor of Science in Engineering, Sciences, or a related field – must.

Required Skills

• At least 3-5 years of experience working in a quality function in the medical device industry – must.
• Experience with ISO 13485, ISO 14971, 21 CFR 820, EU MDR standards – must.
• 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).

Preferred Skills

• 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.
• Familiar with statistical techniques used in verification and validation processes (preferred).