Principal Design Assurance Engineer

Job Type

Full-time

Description

About 4C Med

We are a small but mighty, well-financed team dedicated to proving the effectiveness of our life enhancing, life saving therapy. 4C Medical Technologies, Inc., located in Maple Grove, MN, is developing the first Mitral Regurgitation therapy to expand the treatable patient population and streamline the procedure. Our Alta Valve is currently in the clinical trial phase of FDA approval.

Job Summary

The Principle, Design Assurance Engineer (PDA) is a key member of our innovative team working on cutting-edge technologies in the field of cardiology. The primary responsibility of this role will be to ensure the design assurance of a heart valve and a delivery catheter system.

The Principle, 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

• Pay meticulous attention to detail, strong analytical skills, and robust problem-solving capabilities.
• Provides superior communication to stakeholders and collaborate effectively within a team setting.
• Leads the product development 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.

Requirements

Education:

• Bachelor's degree in a technical field or equivalent professional experience.

Experience:

• 10 to 15 years of experience in medical device industry with at least 3 to 5 years experience in Quality

Knowledge, Skills and Abilities:

• 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 relevant to the company's products.
• Proficient in Microsoft Office applications including Excel, Word, and Outlook, with effective communication abilities, both oral and written.
• Capable of multitasking in a dynamic, fast-paced work environment.
• Able to work collaboratively across all organizational levels.
• Strong leadership skills to manage subordinates, projects, and workflow effectively.
• Exceptional organizational skills and the ability to prioritize multiple tasks.
• Handle confidential and sensitive information with the utmost professionalism.
• Detail-oriented with the flexibility to adapt to the company's evolving needs.
• Knowledgeable in statistics, data collection, analysis, and presentation techniques.
• Excellent interpersonal, communication, and problem-solving skills.
• Capable of working autonomously with minimal supervision, proactively seeking guidance when necessary.
• Skilled in defining, organizing, and managing both individual and team tasks.

Salary Description

$150,000 to $170,000 per year