Senior Systems Engineer – Medical Devices (Reqs & Testing)

Magnendo Corp.; Newton (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Magnendo Corp. is seeking a Senior Systems Requirements & Test Engineer to own requirements decomposition and verification across hardware, software, and sensing subsystems.

You will develop test methods, establish acceptance criteria, and maintain traceability from clinical need to verification across the system. The role requires deep experience in regulated environments for medical devices, with strong skills in requirements management, test case development, and root-cause analysis.

Qualifications

• Requires 6+ years in systems requirements engineering and/or V&V testing in regulated, high-reliability environments (medical device preferred).
• Experience across hardware, software, and sensing subsystems with verifiable requirements.
• Familiarity with FDA/ISO/regulatory frameworks and standards (e.g., FDA 21 CFR 820, ISO 13485, IEC 62304, IEC 60601).

Responsibilities

• Own and maintain system and subsystem requirements across hardware, software, and sensing with full traceability from clinical need to test verification.
• Decompose product and clinical requirements into verifiable system-level requirements for hardware, software, and sensing subsystems.
• Develop test methods, protocols, and acceptance criteria for evaluating candidate technologies and design changes.
• Build and maintain test cases, test reports, and RTMs across system levels.
• Translate product-level requirements into verifiable system-level requirements with design decisions supported by testing data.
• Support risk analysis (e.g., FMEA), design reviews, and root-cause investigations tied to requirements and test failures.
• Contribute to a rigorous quality process aligned with regulatory V-model (IEC 62304, IEC 60601, ISO 13485, ISO 14971).

Skills

Systems requirements engineering

V&V testing

Medical device regulatory knowledge

Requirements traceability

Root-cause analysis

Clear communication

Independent startup mindset

Python and Linux for tooling

Job description

Magnendo Corp. is seeking a Senior Systems Requirements & Test Engineer to own requirements decomposition and verification across hardware, software, and sensing subsystems.

You will develop test methods, establish acceptance criteria, and maintain traceability from clinical need to verification across the system. The role requires deep experience in regulated environments for medical devices, with strong skills in requirements management, test case development, and root-cause analysis.