Design Assurance Engineer

About the Company

Magenta Medical is a Class III medical device company developing the smallest and most powerful heart pump in the world – the Elevate™ System. Designed to deliver minimally invasive cardiac support during acute episodes of heart dysfunction, the Elevate™ System is a multidisciplinary innovation, combining mechanical engineering, material science, electrical engineering, software, algorithms, and advanced catheter fabrication techniques.

As we scale up for commercial manufacturing, we’re entering a phase of rapid growth.

We’re looking for exceptional individuals to help us drive the Elevate™ System forward, build the foundation for long-term success, and most importantly – save lives.

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We're looking for a Quality Design Assurance Engineer to join our growing QA team. In this role, you’ll collaborate closely with R&D, Configuration, Engineering, and Manufacturing teams, working across software, hardware, and mechanical systems to support design excellence 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.

Reports to : QA Manager

Responsibilities

• Quality responsibility to verify that the design and development process follows the procedures and design and development plans.
• Work closely with R&D and test teams to support regulatory requirements by creating, reviewing, and providing quality and compliance input to the design and development process, deliverables, and requirements.
• Participation in project meetings to review and help update clear and concise user requirements, product specifications, plans, verification and validation studies, risk management files, and other relevant design control deliverables.
• Quality responsibility for transferring new products and sustaining projects to manufacturing and operations quality and supplier quality teams.
• Support the Regulatory Affairs department for submissions and respond to submission questions, implementation of new or revised standards and support internal and external audits.

Qualifications

• At least 2-3 years of experience working in a quality function in the medical device industry – must.
• At least 1 year of experience as a design control engineer (preferred).
• A Bachelor of Science in Engineering, Sciences, or a related field – must.
• Familiar with statistical techniques used in verification and validation processes – must.
• Experience with ISO 14971, 21 CR 820, ISO 13485, EU MDR, IEC 60601-1, IEC 62366, and IEC 62304 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.
• Proficient use of standard MS Office applications.
• Fluent in English (oral and written).