In this role, you will be responsible for test measurement systems design and development spanning the full hierarchy of the product hardware. Your focus will include system engineering principles to ensure successful product V&V, which includes test system requirement generation, verification planning, test architecture development, and integration efforts, working across hardware, software, clinical, quality, and regulatory teams. You will play a key role in driving high-quality design outcomes by using risk-based testing and system engineering best practices.
Responsibilities- Develop and own system-level test strategies, including verification plans, test protocols, and acceptance criteria aligned with design inputs, and risk controls
- Work closely with subject matter experts to develop test methods, documentation, and perform verification of custom test measurement systems
- Prepare and execute third party standards testing in conjunction with hardware and software teams
- Lead the development of risk-based test coverage driven by Hazard Analysis, Risk Assessments, and DFMEAs
- Ensure test methods effectively verify safety and performance, requirements at the system, subsystem, and component levels
- Support development and execution of verification and integration testing, including hands-on testing where appropriate
- Lead and coordinate system integration activities, ensuring hardware, software, algorithms, and clinical workflows function together as intended
- Identify, diagnose, and resolve integration issues across disciplines, working closely with design, software, and test teams
- Ensure test development and integration activities align with design control requirements for regulated medical devices
- Contribute to failure analysis, root cause investigations, and corrective actions as needed
- Collaborate with Product Management, Clinical, Hardware, Software, Quality, and Regulatory teams to ensure test and integration efforts meet product and compliance needs
- Communicate test strategy, results, and risks clearly to both technical and non-technical stakeholders
Required Qualifications- BS in Electrical Engineering, Biomedical Engineering, or a related technical field
- 6+ years of experience in medical device or medical imaging product development
- Demonstrated experience with test protocol development, execution, and traceability for regulated products
- Strong background in system integration, verification, and risk-based testing
- Solid understanding of relevant standards and regulations, such as: ISO 13485, ISO 14971, IEC 60601 (system and subsystem level), IEC 62304 (software lifecycle, as applicable).
- Experience working within formal Design Control processes
- Excellent communication, documentation, and cross-functional collaboration skills
Preferred Qualifications- MS in Electrical Engineering, Biomedical Engineering, or a related field
- Experience in medical imaging systems (Ultrasound strongly preferred)
- Experience supporting FDA submissions and regulatory audits
- Ability to write or review test automation, test scripts, or control code (e.g., Python, C/C++)
- Prior experience working in Agile or hybrid development environments
