Senior Medical Device Systems Engineer - Embedded

Systemart, LLC; Olathe (KS); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Health, vision, and dental insurance

Company retirement plan with matching

Job summary

Vantage MedTech in Olathe, Kansas, seeks an experienced Systems Engineer III to lead a development team, documenting, analyzing, mitigating risks, and aiding in the manufacturing of complex electromechanical and embedded medical device systems, including software and hardware aspects.

You will collaborate with software, electrical, mechanical, manufacturing, process, and test engineers through the full product lifecycle, ensure design control and regulatory compliance, and mentor junior

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.
• 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.
• Demonstrated project leadership skills.

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.

Skills

Leadership

Mentorship

Cross-functional collaboration

Education

Bachelor’s degree in mechanical, electrical, or related engineering field

Tools

Source Code Management

Requirements Management

Defect Tracking

Job description

Vantage MedTech in Olathe, Kansas, seeks an experienced Systems Engineer III to lead a development team, documenting, analyzing, mitigating risks, and aiding in the manufacturing of complex electromechanical and embedded medical device systems, including software and hardware aspects.

You will collaborate with software, electrical, mechanical, manufacturing, process, and test engineers through the full product lifecycle, ensure design control and regulatory compliance, and mentor junior