Principal Systems Engineer

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

Principal Systems Engineer

Department: Engineering

Employment Type: Full Time

Location: Burlington, MA

Compensation: $165,000 - $185,000 / year

Description

Why should you join our success story?

Based on patented technology developed at MIT, Harvard Medical School and by the Company, Myomo develops and markets the MyoPro® product line of lightweight, non-invasive, powered arm braces (orthoses) to restore function in paralyzed or weakened arms and hands of individuals that have suffered a stroke, spinal cord, or nerve injury. (E.g. brachial plexus injury or other neuro-muscular disabilities.) It is the only device that, sensing a patient’s own neurological signals through non-invasive wearable sensors, can restore the ability to use their arms and hands so that they can live independently, increase their quality of life, reduce cost of care, and return to work. Published clinical research shows a clinically significant instantaneous reduction in upper extremity impairment with the MyoPro. Our technology has been referred by leading-edge rehabilitation facilities including Mayo Clinic, Kennedy Krieger Institute, Cleveland Clinic, Loma Linda Medical Center, Massachusetts General Hospital, numerous VA Hospitals, and more. Myomo is headquartered in Burlington, Massachusetts, with sales and clinical professionals across the U.S.

What we're looking for:

The Principal Systems Engineer leads system-level design and integration activities for Myomo’s medical device product line. This role defines product architecture, ensures alignment between mechanical, electrical, and software components, and drives innovation aimed at enhancing performance, reliability, and safety. The Principal Systems Engineer provides technical leadership across cross-functional teams, ensuring that Myomo’s products meet user needs, regulatory standards, and business goals.

How You'll Drive Impact:

• 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.

What You'll Bring:

• 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.
• Prior experience defining architecture, requirements, and risk management in compliance with standards such as ISO 13485 and ISO 14971.
• Strong background in innovation and intellectual property development (patent authorship preferred).
• Knowledge of rapid-prototyping and manufacturing processes including 3D printing, CNC machining, and injection molding.
• Familiarity with related engineering domains, including embedded software and electronics.
• Demonstrated ability to manage multiple projects, prioritize effectively, and work independently with minimal supervision.
• Excellent communication, collaboration, and problem-solving skills.
• Attention to detail and strong organizational skills.