Technical Fellow, Systems & Device Engineering

Magnendo Corp.; Newton (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Magnendo Corp. in Newton, MA is seeking an accomplished hardware Systems Engineer to own the hardware subsystems of our endovascular platform, including the robot carts, sensors, and the advancer unit.

You will shape architecture, interfaces, and safety considerations for a medical device at the cutting edge of stroke treatment. You will collaborate with contract manufacturers and external design partners, define usability requirements per IEC 62366-1, and lead guidewire design from concept

Qualifications

• 13+ years with BS / 11+ years with MS / 8+ years with PhD in medical device engineering and robotics.
• Experience owning systems-level hardware architecture across mechanical, electrical, and controls with IEC 60601 compliance.
• Experience defining procedural workflow and usability requirements for UI/UX per IEC 62366-1.
• Background in guidewire, catheter, or related interventional device design under ISO 13485 with contract manufacturers.
• Able to serve as a top technical authority and provide design guidance to engineers and contractors.

Responsibilities

• Own hardware subsystem architecture and requirements for the platform.
• Define interfaces across hardware subsystems balancing mechanical, electrical, magnetic, and controls.
• Collaborate with external hardware design teams and contract manufacturers.
• Lead guidewire design from concept through prototyping and iteration.
• Provide technical oversight across systems, hardware, and guidewire designs.
• Drive design decisions using first-principles analysis, simulation, and prototyping.
• Collaborate with systems, software, robotics, and clinical teams to integrate designs.
• Support ISO 14971 risk management activities and design reviews.

Skills

Medical device engineering

Robotics

Systems-level hardware architecture

UI/UX requirements for medical devices

Regulatory risk management

Education

BS in engineering

MS in engineering

PhD in relevant field

Tools

ISO 13485

IEC 60601 standards

ISO 14971 risk management

IEC 62366-1 usability

Prototype testing

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 systems engineering for the hardware components of our platform, including the carts that house our robot and sensors and the advancer unit that drives the magnetic guidewire and other devices, all in the context of relevant medical device safety standards (e.g., IEC 60601, ISO 14971)
• Define and drive the requirements, architecture, and interfaces across these hardware subsystems, balancing mechanical, electrical, magnetic, and controls considerations
• Partner with i external (contract/vendor) hardware design teams to define, review, and validate mechanical and electromechanical requirements
• Define requirements around procedural workflows and usability that drive our UI/UX design, applying human factors and usability engineering practices consistent with IEC 62366-1, and working closely with clinical, software, and human factors partners
• Lead guidewire design, from concept through prototyping and iteration, in close partnership with our contract manufacturer
• Partner with and provide technical guidance to a process engineer supporting guidewire manufacturing and process development
• Serve as a top technical authority across systems, hardware, and guidewire design, providing technical oversight to internal engineers and external contractors and partners
• Drive design decisions using first-principles engineering analysis, simulation, and hands-on prototyping and testing
• Define and review requirements, test plans, and acceptance criteria across the hardware and guidewire subsystems you own
• Collaborate closely with systems, software, robotics, and clinical teams to integrate your designs into the broader system
• Support risk analysis, design reviews, and root-cause investigations across your areas of ownership, consistent with ISO 14971 risk management practices

Help mature design and quality processes appropriate for a regulatory V-model framework as the company scales toward clinical and commercial products (e.g., ISO 13485, ISO 14971)

You Are

• 13 + years of experience (BS) / 11+ years (MS) / 8+ years (PhD) with hands-on experience in both medical device engineering and robotics across hardware systems, workflow/UX, and minimally invasive medical device design
• Demonstrated experience owning systems-level hardware architecture and requirements across mechanical, electrical, and controls disciplines, with designs that have met medical device standards such as IEC 60601
• Experience defining procedural workflow and usability requirements that inform UI/UX design, shaped by usability engineering standards such as IEC 62366-1, in a clinical or procedural setting
• Background in guidewire, catheter, or related interventional device design under ISO 13485 design controls, including work with contract manufacturers and awareness of biocompatibility requirements (ISO 10993)
• Comfortable serving as a top technical authority - providing design guidance and review to internal engineers, external contractors, and future direct reports alike
• Proven track record of innovative technical problem-solving, backed by a portfolio of patents or other tangible evidence of novel contributions to the field
• Able to operate with the judgment and independence expected of a Technical Fellow, setting technical direction with limited oversight across multiple disciplines, while holding the line on rigor where it matters most
• Excellent communicator, able to clearly convey complex technical tradeoffs across hardware, workflow, and device design to cross-functional teams and external partners
• An adept, fast learner who is comfortable in a fast-paced environment

Bonus Points

• Experience with design considerations for systems operating in the presence of a strong magnetic field
• Prior experience managing or partnering closely with a process engineer or manufacturing engineering function
• Track record of patents, publications, or industry recognition reflecting deep technical expertise

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.