Senior Design Assurance Engineer — MedTech & IEC 62304

HistoSonics, Inc.; Plymouth (MN); On-site; USD 150,000 - 175,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k)

Job summary

HistoSonics, a commercial-stage medtech company, seeks a Principal Design Assurance Engineer in Plymouth, MN to lead design assurance strategy across the product portfolio. You’ll work with cross-functional teams to define requirements, verification and validation plans, and ensure compliance with IEC 62304 and ISO 14971 throughout software and hardware development.

Responsibilities include leading design reviews, risk management, and regulatory collaboration while mentoring engineers and

Qualifications

• Bachelor's degree in Engineering, Computer Science, or a related technical discipline.
• 10+ years of progressive quality or design assurance experience in medical devices.
• Expert-level competency in design control lifecycle tools and processes.
• Deep expertise in medical device software/firmware development and IEC 62304.
• Experience with SAFe AGILE Framework and integrating design control deliverables.
• Knowledge of 21 CFR 820 / FDA QMSR, ISO 13485, EU MDR, ISO 14971, IEC 60601, IEC 62304.
• Strong analytical and problem-solving skills; attention to detail.

Responsibilities

• Lead product design requirements that are unambiguous, testable, and traceable.
• Define verification and validation strategies and drive closure through protocols.
• Collaborate with Software teams across the life cycle per IEC 62304.
• Lead design reviews to support Product Development Phase Closure.
• Support product safety risk management and systemic improvements.
• Review design documentation to ensure accuracy and regulatory compliance.
• Mentor engineers on regulatory standards and design practices.
• Contribute to usability engineering protocols and evaluations.
• Participate in audits and inspections for risk management.

Skills

Design assurance

Medical devices

IEC 62304

FDA CFR 820

Quality systems

SAFe Agile

Risk management

V&V

Traceability

Design reviews

Education

Bachelor's degree in engineering

Tools

SOUP management

Requirements management tools

Job description

HistoSonics, a commercial-stage medtech company, seeks a Principal Design Assurance Engineer in Plymouth, MN to lead design assurance strategy across the product portfolio. You’ll work with cross-functional teams to define requirements, verification and validation plans, and ensure compliance with IEC 62304 and ISO 14971 throughout software and hardware development.

Responsibilities include leading design reviews, risk management, and regulatory collaboration while mentoring engineers and