Principal Systems Engineer - Medical Devices Architect

Myomo Inc.; Burlington (MA); Hybrid; USD 165,000 - 185,000; Full time

Job summary

Myomo, Inc. is seeking a Principal Systems Engineer in Burlington, MA to lead system-level design for our medical device products. You will align mechanical, electrical and software components, drive innovation, and ensure safety and regulatory compliance.

The role requires 10–15 years in product development with 5+ years in medical devices, strong architecture definition, and a track record of leading cross-functional teams. Join a team advancing cutting-edge orthotic technology.

Qualifications

• Bachelor’s or Master’s degree in Biomedical, Mechanical, Electrical, or Systems Engineering.
• 10-15 years of product development experience, including 5+ years in the medical device industry.
• Proven track record of leading system design and integration for complex electromechanical products.

Responsibilities

• Lead design, development, and integration of medical devices and mechatronic subsystems to meet customer and business needs.
• Define and maintain system architecture across hardware, software, and user interfaces in collaboration with engineering and product management.
• Translate customer and business requirements into functional, performance, and safety specifications.
• Drive risk management and system-level verification and validation activities in accordance with medical device standards.
• Develop prototypes, evaluating design concepts, driving innovative solutions in support of Myomo’s intellectual property portfolio.
• Ensure design intent and product reliability through cross-functional collaboration with Quality, Manufacturing, Clinical, and Customer support.
• Apply requirements-driven design and systems engineering principles to manage trade-offs across cost, schedule, and performance.
• Identify and mitigate technical and project risks, ensuring timely communication and resolution.
• Promote continuous improvement in engineering processes, design practices, and documentation standards.
• Mentor engineers across disciplines and fostering a collaborative, innovative engineering culture.

Skills

System design

Integration

Medical devices

ISO 13485

ISO 14971

Embedded software

IP development

Communication

Mentoring

Independent work

Education

Bachelor’s degree

Master’s degree

Tools

3D printing

CNC machining

Injection molding

Rapid prototyping

Job description

Myomo, Inc. is seeking a Principal Systems Engineer in Burlington, MA to lead system-level design for our medical device products. You will align mechanical, electrical and software components, drive innovation, and ensure safety and regulatory compliance.

The role requires 10–15 years in product development with 5+ years in medical devices, strong architecture definition, and a track record of leading cross-functional teams. Join a team advancing cutting-edge orthotic technology.