Senior Medical Systems Engineer – Onsite, Olathe

Vantage MedTech; Olathe (KS); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Health, Vision & Dental insurance

Generous Paid Time Off

Retirement plan with matching

Job summary

Vantage MedTech in Olathe, KS is seeking a Senior Systems Engineer to lead cross-functional development of electromechanical, embedded medical device systems, spanning requirements, archi tecture, testing, and manufacturing transfer.

You will mentor junior engineers, drive design controls, and collaborate with PMs, clinicians, and clients to deliver compliant, high-quality solutions on schedule. This is an on-site role in the Kansas City area.

Qualifications

• Bachelor's degree in mechanical, electrical, or related engineering field (required).
• 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 medical devices testing.
• Experience with white box testing and automated testing.
• Knowledge of FDA class II/III regulatory requirements or similar regulated environments.
• 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 across 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 objectives.
• Develop and execute verification and validation strategies with 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.
• Participate in risk management, design reviews, and phase gate reviews for safety and compliance.
• Support product development from concept through commercialization, including manufacturing transfer.
• Mentor junior engineers and promote best practices and process improvements.
• Partner with project managers, clients, clinicians, and stakeholders to deliver solutions on schedule and budget.

Skills

Project leadership

White box testing

Automated testing

Regulatory compliance

Technical documentation

Education

Bachelor's degree in mechanical/electrical engineering

Tools

Source Code Management

Requirements Management

Defect Tracking systems

Job description

Vantage MedTech in Olathe, KS is seeking a Senior Systems Engineer to lead cross-functional development of electromechanical, embedded medical device systems, spanning requirements, archi tecture, testing, and manufacturing transfer.

You will mentor junior engineers, drive design controls, and collaborate with PMs, clinicians, and clients to deliver compliant, high-quality solutions on schedule. This is an on-site role in the Kansas City area.