Senior System 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

The Systems Engineer leads a development team to document, analyze, mitigate risks, create, test, and help with the manufacturing of complex electromechanical and embedded medical device systems, including both software and hardware aspects with Embedded, Real-time, PC, Linux, and Windows applications. The Systems Engineer III collaborates with cross functional engineering team in all stages of new product development from requirements management and system architecture to product commercialization and Manufacturing. The Systems Engineer III often consults with clients to determine system specifications and write requirements. Provides technical expertise, guidance, and mentorship to Systems Engineers. Collaborates with PMs to develop proposals.

Key Responsibilities:

• Lead systems engineering activities, including requirements development, system architecture, and product design for medical device projects.
• Collaborate with cross-functional teams, including software, electrical, mechanical, manufacturing, process, and test engineers throughout the product lifecycle.
• Analyze customer and product requirements to define system-level specifications and ensure alignment with business and technical objectives.
• Develop and execute verification and validation strategies, including test plans, procedures, protocols, and reports.
• Maintain requirements traceability and ensure compliance with design control, quality, and regulatory requirements.
• Troubleshoot and resolve complex system, hardware, software, and product design issues to support successful project execution.
• Participate in risk management activities, design reviews, and phase gate reviews to ensure product safety, performance, and compliance.
• Support product development from concept through commercialization, including manufacturing transfer and production support activities.
• Mentor and provide technical guidance to junior engineers while driving engineering best practices and process improvements.
• Partner with project managers, clients, clinicians, and other stakeholders to deliver innovative solutions on schedule and within budget.

Education and Experience:

• 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
• Experience with Source Code Management, Requirements Management, and Defect Tracking systems
• Experience providing written reports, test protocols, and engineering documentation for the testing of medical devices
• Experience with “white box” testing and automated testing
• Experience with FDA class II or III medical device regulatory requirements, or experience in similar regulated product development environment
• Advanced knowledge of ISO 13485/14971, 93/42/EEC, 90/385/EEC, EN45502, EN60601-1, EN61000.