Lead Medical Device Systems Engineer

Professional Employment Group of Colorado; United States; On-site; USD 120,000 - 160,000; Full time

Job summary

Professional Employment Group of Colorado seeks a Systems Engineer III to lead a development team responsible for documenting, analyzing, mitigating risks, and supporting the manufacture of complex electromechanical and embedded medical device systems. The role spans software and hardware with Embedded, Real-time, PC, Linux, and Windows applications.

You will mentor junior engineers, collaborate with cross‑functional teams, and work with PMs to develop proposals, while ensuring quality and

Qualifications

• Bachelor’s degree in mechanical, electrical, or related engineering field.
• 8–10 years of professional experience in electromechanical and embedded systems product development.
• Experience with medical device development under quality systems.

Responsibilities

• Lead systems engineering activities including requirements development and system architecture.
• Collaborate with software, electrical, mechanical, manufacturing, and test engineers throughout the product lifecycle.
• Define system-level specifications from customer requirements and ensure alignment with objectives.
• Develop and execute verification and validation strategies with test plans and protocols.
• Maintain requirements traceability and ensure compliance with design controls and regulatory requirements.
• Troubleshoot and resolve complex system, hardware, software, and product design issues.
• Participate in risk management activities, design reviews, and phase gate reviews.

Skills

Requirements development

System architecture

Product design

Cross-functional collaboration

Mentorship

Regulatory knowledge

Education

Bachelor’s degree in mechanical/electrical engineering

Tools

Source Code Management

Requirements Management

Defect Tracking

Job description

Professional Employment Group of Colorado seeks a Systems Engineer III to lead a development team responsible for documenting, analyzing, mitigating risks, and supporting the manufacture of complex electromechanical and embedded medical device systems. The role spans software and hardware with Embedded, Real-time, PC, Linux, and Windows applications.

You will mentor junior engineers, collaborate with cross‑functional teams, and work with PMs to develop proposals, while ensuring quality and