Certainly! Here s a concise and structured summary of the role you described, suitable for use in a job posting, team introduction, or even as an interview prep cheat sheet:

Medical Device System Test Engineer Ultrasound

Role Overview

As a System Test Engineer for diagnostic ultrasound devices, you will design, execute, and automate verification and validation (V&V;) testing for ultrasound systems and transducers. Your work ensures image quality, safety, and regulatory compliance across multiple imaging modalities, supporting release readiness in a highly regulated medical device environment.

Core Responsibilities

- Test Planning & Execution:
- Develop and maintain traceable test plans, protocols, and reports.
- Perform and automate functional, performance, and workflow tests (B-mode, M-mode, Doppler, 3D/4D, Elastography).
- Use phantoms to measure and analyze image quality parameters (resolution, contrast, penetration, Doppler accuracy).
- Data & Connectivity Validation:
- Validate DICOM, HL7, PACS workflows, metadata integrity, and PHI compliance (HIPAA/GDPR).
- Safety & Standards Compliance:
- Ensure product meets IEC 60601-2-37, IEC 60601-1, IEC 62304, ISO 14971, and related standards.
- Support risk-based testing and traceability to hazard analyses and post-market feedback.
- Defect Management & Collaboration:
- Log, triage, and drive closure of defects with R&D;, Systems, Acoustics, and Clinical teams.




- Work closely with clinical specialists to translate real-world use into test scenarios.
- Documentation & Release Readiness:
- Prepare test summary reports and maintain evidence for audits, design reviews, and regulatory submissions.
- Support manufacturing test transfer and service diagnostics as needed.

Nice to Have / Leadership Opportunities

- Lead V&V; strategy, coach junior engineers, manage V&V; budget/schedule.
- Define acceptance criteria, sampling plans, and confidence levels for release.
- Excellent communication and teamwork across disciplines.

Preferred/Bonus Skills

- Familiarity with IEC 60601-2-37, IEC 62304, ISO 14971, IEC 62366, ISO 13485 QMS.
- Experience with probe technologies (phased array, linear, convex), cable/connector testing, and reliability testing.

Tools & Equipment

- Phantoms: AIUM-type grayscale, Doppler flow, uniformity, elastography.
- Software: DICOM tools, DOORS, CodeBeamer, Windchill, TeamTrack.

Ideal Candidate Profile

- Blend of clinical knowledge, system/hardware understanding, rigorous testing discipline, and data-driven troubleshooting.
- Self-motivated, detail-oriented, with robust cross-functional communication skills.

Let me know if you d like this tailored further (e.g., for a specific company, as a resume bullet, or as an interview question list)!

📌 Ultrasound System Testing Expert (Bengaluru)
🏢 Sonyo Management Consultants
📍 Bengaluru