Moonrise Medical is early-stage medical device startup developing advanced ultrasound imaging to address peripheral artery disease.

Role Summary

Moonrise Medical is seeking a multi-disciplinary quality engineer to lead both software verification & validation (V&V) and hardware design quality activities for our regulated ultrasound system. You will own and maintain the Design History File (DHF), ensure compliance with FDA and international standards, and work closely with engineering to validate both hardware and software performance.

This role is ideal for someone who understands the entire medical device lifecycle—from software algorithms to physical device testing—and is ready to build a robust, compliant, and auditable foundation for regulatory submission.

Key Responsibilities

Software QA / V&V

• Develop and execute software test protocols (unit, integration, system-level)

• Define software verification strategy per IEC 62304

• Maintain traceability from software requirements to test results

• Coordinate system-level testing across software and hardware interfaces

• Ensure compliance with 21 CFR Part 11 (audit trails, signatures, etc.)

Hardware Design Quality

• Collaborate with hardware engineers to develop and document verification protocols for mechanical, electrical, and system-level components

• Ensure hardware design outputs are verified against inputs and linked to risk controls

• Support test method validation for hardware V&V

• Coordinate or oversee hardware test execution and result documentation

• Participate in supplier quality reviews, component selection, and inspection planning (as applicable)

Design Controls & DHF Ownership

• Structure and maintain the complete Design History File across hardware and software

• Develop and manage traceability matrices (requirements → risks → V&V)

• Participate in risk management (FMEA) activities and mitigation tracking

• Lead documentation preparation for design reviews, design freeze, and submission readiness

Regulatory & QMS Support

• Contribute to 510(k) documentation, especially software and V&V sections

• Ensure compliance with 21 CFR 820, ISO 13485, and ISO 14971

• Help build scalable, Part 11-compliant document control and design change processes

Qualifications

Required

• 5+ years in medical device quality, V&V, or software QA

• Experience testing and validating both hardware and software in regulated devices

• Strong working knowledge of IEC 62304, ISO 13485, ISO 14971, 21 CFR 820, and IEC 60601-1

• Familiarity with hardware testing protocols and documentation

• Proven ability to manage and write DHF documentation and traceability

• Strong communication skills and comfort collaborating cross-functionally

Nice to Have

• Experience with ultrasound systems, image/signal processing, or electromechanical devices

• Familiarity with Part 11-compliant tools (e.g., Greenlight Guru, MasterControl, or similar)

• Background in hardware or systems engineering a plus