Senior Medical Device Systems Engineer | Lead & Mentor

vantagemedtech; Olathe (KS); On-site; USD 110,000 - 160,000; 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 seeks an experienced Senior Systems Engineer to lead systems engineering activities across electromechanical and embedded medical device projects. You will collaborate with software, electrical, mechanical, manufacturing, and test teams to ensure design integrity from concept to production.

The role requires 8-10 years in the field, strong regulatory knowledge (FDA/ISO), and mentoring of junior engineers.

Qualifications

• 8-10 years of professional experience in electromechanical and embedded systems product development.
• Experience with medical device development under quality systems.
• Experience with FDA class II or III regulatory requirements or similar regulated environments.
• Advanced knowledge of ISO 13485/14971, 93/42/EEC, 90/385/EEC, EN45502, EN60601-1, EN61000.

Responsibilities

• Lead systems engineering activities, including requirements development, system architecture, and product design for medical device projects.
• Collaborate with software, electrical, mechanical, manufacturing, process, and test engineers throughout the product lifecycle.
• 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 project execution.
• Participate in risk management activities, design reviews, and phase gate reviews to ensure product safety and compliance.
• Support product development from concept through commercialization, including manufacturing transfer and production support.
• Mentor and provide technical guidance to junior engineers; drive engineering best practices and process improvements.
• Partner with project managers, clients, clinicians, and stakeholders to deliver innovative solutions on schedule and within budget.

Skills

Requirements management

System architecture

Risk management

Mentorship

Cross-functional collaboration

Systems engineering

Education

Bachelor's degree in engineering

Tools

Source code management

Defect tracking systems

Requirements management systems

Automated testing tools

Job description

Vantage MedTech in Olathe, KS seeks an experienced Senior Systems Engineer to lead systems engineering activities across electromechanical and embedded medical device projects. You will collaborate with software, electrical, mechanical, manufacturing, and test teams to ensure design integrity from concept to production.

The role requires 8-10 years in the field, strong regulatory knowledge (FDA/ISO), and mentoring of junior engineers.