Principal Design Assurance Engineer (Medical Devices)

Location: Fridley, Minnesota, United States

Company

hirify.global is a commercial-stage medtech company developing Vivistim® Paired VNS™ Therapy, an FDA-approved implantable solution designed to improve upper-limb function in chronic ischemic stroke survivors.

What you will do

• Lead design assurance activities for new hardware and electrical medical device products.
• Support product sustaining activities, including failure analysis, design changes, supplier evaluations, complaint investigations, and nonconformance disposition.
• Lead root-cause investigations, corrective actions, effectiveness verification, and technical investigations.
• Support compliant development, verification, validation, and transfer of products and processes into manufacturing.
• Maintain Design History Files and design risk management documentation while supporting design and phase-gate reviews.
• Collaborate with Product Development, Sustaining Engineering, Quality, Regulatory, and Operations teams; provide technical leadership and mentoring.

Requirements

• Bachelor’s degree in Electrical, Biomedical, Mechanical Engineering, or a related discipline, with 10+ years of progressive experience, or an equivalent combination of education and experience.
• Experience applying hardware and electrical design controls in regulated industries, including medical device design controls, risk management, new product development, DHF maintenance, and verification and validation.
• Hands-on expertise with analog and digital circuits, power management, embedded systems, electromechanical interfaces, schematics, PCB layouts, and component selection.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601, IEC 61010, ISO 10993, and EU MDR, as applicable.
• Experience developing and validating test methods, with strong analytical, communication, organizational, and problem-solving skills.
• Ability to lead technical teams through collaboration and influence, work independently, and exercise sound judgment.

Nice to have

• Quality engineering experience or certification.
• Proficiency with Microsoft Office and engineering or documentation tools.

Culture & Benefits

• Medical, dental, and vision insurance plans.
• Flexible Spending Account.
• 401(k) plan with company matching.
• Unlimited paid time off.
• Approximately 18 paid company holidays per year.
• Equal employment opportunities and a workplace free from discrimination and harassment.