A client is looking to hire a Principal Design Assurance Engineer onsite in Maple Grove. This person will be working on cutting-edge technologies in the field of cardiology and should have experience bringing a class III device through the pre-market regulatory pathway. The primary responsibility of this role will be to ensure the design assurance of a heart valve and a delivery catheter system.

This Design Assurance Engineer should possess a background in the medical device industry with emphasis on cardiological devices, including implantable heart valves and transcatheter delivery systems and possess a strong understanding of regulations and standards such as 21 CFR 820 and ISO 13485. Ideal candidates will have experience in a variety of functions related to design assurance, including but not limited to risk management (in accordance with ISO 14971), design verification and validation (aligned with EN ISO 5840-1/-2/-3), and quality management systems.

Essential Functions

• Possesses a meticulous attention to detail, strong analytical skills, and robust problem-solving capabilities.
• Demonstrates superior communication skills and the capacity to collaborate effectively within a team setting.
• Leads the product development process including key design assurance activities, design reviews, verification and validation activities, development and validation of testing methods, management of product requirements, test case tracing, and risk management.
• Facilitates the transition of new product development into production.
• Conducts reviews and enhancements of Quality Management System (QMS) processes related to design controls, design assurance activities, and EN ISO 5840 compliance requirements.
• Gathers, analyzes, and presents data, employing statistical tools and other analytical methodologies.
• Actively engages with team members and contributes to discussions. Demonstrates strong verbal and written communication skills and adaptability for rapid iteration and flexibility in design and strategy changes.

Position requirements:

• Requires a minimum of a Bachelor’s degree in a technical field or equivalent professional experience.
• 10 to 15 years of experience in medical device industry
• 3 to 5 years experience in Quality.
• Possess a deep understanding of ISO 13485, CE Marking, EN ISO 5840, EU MDR (formerly MDD), FDA Medical Device Regulation (MDR), and FDA requirements.
• Extensive knowledge of manufacturing processes and practices
• Knowledgeable in statistics, data collection, analysis, and presentation techniques.

Salary of $145 - $165K, depending on experience