Senior Hardware Systems Engineer – Medical Devices

Magnendo; Newton (MA); Hybrid; USD 120,000 - 160,000; Full time

Job summary

Magnendo Corp. in Newton, MA is seeking a Senior Mechanical & Hardware Systems Engineer to own hardware requirements and guide early prototype builds toward a clinically ready system.

You will work hands-on with fixtures and mechanisms, define tests, ensure traceability, and collaborate with internal and external design teams under a rigorous V-model quality framework (ISO 13485, ISO 14971).

Qualifications

• 6+ years of experience in mechanical or systems engineering in a regulated, high-reliability environment
• Ability to translate product/clinical requirements into verifiable mechanical/electromechanical system requirements
• Hands-on experience building and iterating early-stage prototypes and fixtures
• Experience designing and executing tests to characterize concept/design performance
• Comfortable collaborating with internal teams and external design or contract manufacturing partners
• Experienced with requirements and test-case management/traceability tools (Jama/DOORS/Polarion)
• Strong root-cause analysis and debugging skills across mechanical/electromechanical systems
• Able to operate with startup-level autonomy and maintain rigor where it matters most

Responsibilities

• Own and define system and subsystem hardware requirements with traceability from clinical/product need through verification
• Partner with internal and external hardware design teams to review and validate mechanical/electromechanical requirements
• Contribute to early prototype builds, working hands-on with fixtures and mechanisms
• Design and run tests to evaluate concept-level performance and inform go/no-go decisions
• Develop test methods, protocols, and acceptance criteria for subsystems
• Build and maintain test cases, reports, and requirements traceability matrices
• Support root-cause investigations and design iteration based on test data
• Support risk analysis and design reviews for mechanical/hardware requirements
• Contribute to a rigorous quality process blending modern hardware practices with a regulatory V-model

Skills

Mechanical engineering

Systems engineering

Requirements management

Prototype development

Test design

Vendor collaboration

Regulatory compliance

Tools

Jama/DOORS/Polarion

Job description

Senior Mechanical & Hardware Systems Engineer

Newton, MA

(On-Site)

Full-time

Last Update on

July 27, 2026

About the Role

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 Mechanical & Hardware Systems Engineer to own hardware requirements, work hands-on with early prototype builds, and help guide both internal and external design teams toward a system ready for clinical use.

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.