Principal Design Assurance Engineer (Medical Devices)

Location: Hybrid in Plymouth, MN, US; travel up to 10%, primarily within the United States, to hirify.global offices and/or clinical study sites.

Salary: $150,000–$175,000 annually.

Company

hirify.global is a commercial-stage medtech company developing the Edison® System, a non-invasive sonic beam therapy based on histotripsy, with current liver tumor applications and clinical and pipeline development across additional disease areas.

What you will do

• Lead design assurance strategy and execution across the product portfolio from concept through launch and commercialization.
• Partner with Regulatory, R&D, Engineering, Software, and Product Development teams to establish clear, testable, traceable requirements linked to user needs and risk controls.
• Define and drive verification and validation strategies, including test methods, acceptance criteria, statistical rationale, sampling justification, protocols, and reports.
• Support software design assurance across the development lifecycle, including safety classification, SOUP management, software risk management, and software verification and validation.
• Lead design reviews, usability engineering activities, product safety risk management, design documentation reviews, and Design History File quality activities.
• Improve design and development processes, the Quality Management System, non-product software validation, inspection strategies, supplier requirements, and systemic approaches to design quality issues.

Requirements

• Bachelor’s degree in Engineering, Computer Science, or a related technical discipline.
• 10+ years of progressive quality or design assurance engineering experience, including significant hands-on experience developing and commercializing medical devices.
• Expert-level competency across the design control lifecycle, including requirements development and decomposition, traceability, risk management, verification and validation planning and execution, test method development and validation, statistical techniques, sampling rationale, design review leadership, and Design History File construction.
• Deep expertise in medical device software and firmware development and software design assurance under IEC 62304, including software safety classification, SOUP management, software risk management, and software verification and validation.
• Experience with SAFe Agile or a comparable agile framework and integrating design control deliverables into an agile cadence.
• Applied knowledge of 21 CFR 820/FDA QMSR, ISO 13485, EU MDR, ISO 14971, the IEC 60601 series, IEC 62304, and IEC 62366.
• Strong analytical, critical-thinking, problem-solving, attention-to-detail, and organizational skills.
• Ability to travel up to 10%, primarily within the United States.

Nice to have

• Deep expertise in medical device software and firmware development and software design assurance under IEC 62304, including software safety classification, SOUP management, software risk management, and software verification and validation.
• Working understanding of electrical and mechanical engineering principles.
• Understanding of ultrasound physics.

Culture & Benefits

• Work in a commercial-stage medtech environment connecting cutting-edge science with clinical applications.
• Health, dental, and vision insurance.
• Life, short-term disability, and long-term disability insurance.
• 401(k) and paid time off.
• Equal opportunity workplace committed to diversity and non-discrimination.
• Visa sponsorship is not available for this position.