Senior Mechanical & Hardware Systems Engineer

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

Job summary

Magnendo Corp. is developing robotic technology to advance endovascular interventions. Join a fast-growing startup shaping hardware and software for safer, faster stroke treatment and broader access.

As a Senior Mechanical/Systems Engineer, you will define hardware requirements, partner with design teams, prototype, test, and ensure traceability in a regulated environment under ISO 13485/14971.

Qualifications

• 6+ years of experience in mechanical or systems engineering in regulated environments (medical device preferred)
• Experience translating product/clinical requirements into verifiable mechanical/electromechanical system requirements
• Hands-on experience building and iterating on early-stage prototypes and fixtures
• Experience designing and executing tests to characterize concept/design performance

Responsibilities

• Define and manage hardware requirements with traceability from clinical needs through verification
• Collaborate with internal and external (contract/vendor) hardware design teams to review and validate mechanical requirements
• Contribute to early builds of prototypes and fixtures, working hands-on with mechanisms
• Design and run tests to evaluate concept-level design performance and inform go/no-go decisions
• Develop test methods, protocols, and acceptance criteria for subsystems
• Build and maintain test cases, test reports, and requirements traceability matrices
• Support root-causes investigations and design iteration based on test data
• Support risk analysis and design reviews for mechanical/hardware requirements
• Contribute to a rigorous quality process aligned with ISO 13485/14971

Skills

Mechanical design

Systems engineering

Requirements tracing

Prototyping

Test design

Root-cause analysis

Tools

Jama

DOORS

Polarion

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.

You Will

• Own and define system and subsystem-level hardware requirements, ensuring traceability from clinical/product need through verification
• Partner with internal and external (contract/vendor) hardware design teams to define, review, and validate mechanical and electromechanical requirements
• Contribute to early builds of prototypes, working hands‑on with fixtures, mechanisms, and early hardware iterations
• Design and run tests to evaluate concept‑level design performance and inform go/no‑go decisions on candidate hardware approaches
• Develop test methods, protocols, and acceptance criteria for mechanical and electromechanical subsystems
• Build and maintain test cases, test reports, and requirements traceability matrices across the system and subsystem levels
• Support root‑cause investigations and design iteration based on test data and prototype builds
• Support risk analysis and design reviews for mechanical and hardware‑related requirements
• Contribute to a rigorous quality process that blends modern hardware development practices with a regulatory V‑model framework (e.g., ISO 13485, ISO 14971)

You Are

• 6+ years of experience in mechanical or systems engineering, developing and testing hardware within a regulated, high‑reliability environment (medical device preferred; aerospace, automotive, or similar also considered)
• Experienced translating product/clinical requirements into verifiable mechanical and electromechanical system requirements
• Hands‑on experience building, assembling, and iterating on early‑stage prototypes and fixtures
• Experienced designing and executing tests to characterize concept and design performance
• Comfortable working with both internal engineering teams and external design or contract manufacturing partners
• Experienced with requirements and test case management/traceability tools (e.g., Jama, DOORS, Polarion, or similar)
• Strong root‑cause analysis and debugging skills across mechanical and electromechanical systems
• 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
• An adept, fast learner who is comfortable in a fast‑paced environment

Bonus Points

• Electrical engineering skills, comfortable working with sensors and basic circuits/instrumentation
• Experience in the medical device industry, ideally with interventional or robotic systems
• Experience taking a system through a first-in-human or early feasibility clinical trial
• 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.