Senior Systems Engineer

Vantage MedTech provides comprehensive design and manufacturing services, supporting the advancement of medical technologies from concept through to product realization. We develop and manufacture new products for the treatment of heart failure, cancer, stroke, Gene Therapy, COPD, TBI, Atrial Fibrillation, Blood Clots, Brain Surgery, and many more.

About the role

The Senior 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. This role collaborates with cross-functional engineering teams in all stages of new product development—from requirements management and system architecture to product commercialization and manufacturing. The Senior Systems Engineer consults with clients to determine system specifications, writes requirements, provides technical expertise and mentorship to junior engineers, and collaborates with project managers to develop proposals.

This is an on-site position based in Olathe, KS. Candidates must either be local or willing to relocate to the Kansas City metro area.

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

Requirements

• 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

Benefits

• Comprehensive benefits package, including health, vision, and dental insurance
• Generous Paid Time Off
• Company retirement plan with matching