Systems Architecture Lead – Medical Devices

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

Job summary

Myomo, Inc. in Burlington, MA is seeking a Principal Systems Engineer to lead system-level design and integration for its medical device product line. You will align hardware, software, and mechano-electrical subsystems, driving innovation while meeting regulatory and business goals.

The role requires 10–15 years in product development, including 5+ years in the medical device field, with a track record of architecture definition, risk management, and cross-functional leadership.

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.
• Experience defining architecture, requirements, and risk management in compliance with ISO 13485 and ISO 14971.
• Strong background in innovation and IP development (patent authorship preferred).
• Knowledge of rapid prototyping and manufacturing processes including 3D printing, CNC machining, and injection molding.
• Familiarity with embedded software and electronics.

Responsibilities

• Lead system-level design and integration for Myomo’s medical device product line.
• Define product architecture across hardware, software, and user interfaces 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 per medical device standards.
• Develop prototypes and evaluate design concepts to advance IP portfolio.

Skills

System design leadership

Cross-functional collaboration

Regulatory standards awareness

Problem-solving

Education

Bachelor’s or Master’s degree in Biomedical, Mechanical, Electrical, or Systems Engineering

Tools

3D printing

CNC machining

Injection molding

Job description

Myomo, Inc. in Burlington, MA is seeking a Principal Systems Engineer to lead system-level design and integration for its medical device product line. You will align hardware, software, and mechano-electrical subsystems, driving innovation while meeting regulatory and business goals.

The role requires 10–15 years in product development, including 5+ years in the medical device field, with a track record of architecture definition, risk management, and cross-functional leadership.