Senior Systems Requirements & Test Engineer

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

Every minute matters in stroke treatment. Magnendo is developing robotic technology to make life-saving endovascular procedures faster, safer, and more accessible. By combining advanced robotics, magnetic navigation, and intelligent software, we are tackling one of the most technically demanding challenges in healthcare while aiming to expand access to advanced stroke care for patients around the world. Join us in shaping the future of endovascular intervention.

We're looking for a Senior Systems Requirements & Test Engineer to own requirements decomposition and verification across our hardware, software, and sensing subsystems.

You Will

• Own and maintain system and subsystem requirements across hardware, software, and sensing, ensuring full traceability from clinical need through test verification
• Decompose product-level and clinical requirements into verifiable, testable system and subsystem requirements spanning electromechanical hardware, software, and sensing subsystems
• Develop test methods, protocols, and acceptance criteria to evaluate candidate technologies and design changes
• Build and maintain test cases, test reports, and requirements traceability matrices (RTMs) across the system and subsystem levels
• Partner with hardware, software, and sensing/algorithms engineers to translate product-level requirements into verifiable system-level requirements, and support design decisions with data from testing
• Support risk analysis (e.g., FMEA), design reviews, and root-cause investigations tied to requirements and test failures
• Contribute to a rigorous quality process that blends modern, high-reliability hardware/software development practices with a regulatory V-model framework (e.g., IEC 62304, IEC 60601, ISO 13485, ISO 14971)

You Are

• 6+ years of experience in systems requirements engineering and/or V&V testing within a regulated, high-reliability environment (medical device strongly preferred; aerospace, automotive, or similar also considered)
• Experienced developing and verifying requirements across integrated hardware, software, and sensing/sensor subsystems
• Working knowledge of medical device regulatory frameworks and standards (e.g., FDA 21 CFR 820, ISO 13485, EU MDR, IEC 62304, IEC 60601, ISO 14971)
• Experienced with requirements and test case management/traceability tools (e.g., Jama, DOORS, Polarion, or similar)
• Strong root-cause analysis and debugging skills across hardware, software, and sensing interfaces
• Able to operate with the judgment and independence of an early startup hire — comfortable defining process where none exists yet, while holding the line on rigor where it matters most
• Excellent written and verbal communication skills, with the ability to translate clinical and product-level needs into precise, verifiable engineering requirements
• An adept, fast learner who is comfortable in a fast-paced environment

Bonus Points

• Experience in interventional, robotic, or other complex electromechanical medical devices
• Experience with sensor/sensing subsystem V&V (e.g., optical tracking, EM tracking, force/torque sensing, imaging)
• Comfortable with Python and Linux for building test tooling and automation
• Experience writing software and scripts to automate testing of hardware, software, and sensing subsystems, increasing test coverage and repeatability as the system matures
• Experience taking a device through FDA submission (510(k), De Novo, or PMA) or through a first-in-human/early feasibility clinical trial
• Familiarity with structured process-improvement methodologies (Lean, DOE, root-cause analysis, or equivalent)
• Familiarity with magnetic actuation, catheter/guidewire systems, or neurovascular/endovascular devices

Magnendo Corp. is an equal opportunity employer and considers all qualified applications without regard to any characteristic protected by applicable law. We also participate in E-Verify. Employment offers are contingent upon successful completion of employment authorization verification (Form I-9) through E-Verify after hire.