Senior Systems Engineer

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

Job Title: Senior Systems Engineer Location: Olathe, KS Department: Technical Services Reports to: Engineering Manager

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! We are searching for top-tier talent to apply their gifts to making life better for hundreds of thousands of patients worldwide.If this is something you aspire to, we would like to talk with you!

We are seeking an experienced Systems Engineer to join our team. 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.

This is not a remote opportunity. This position is based in Olathe, KS. Candidate must either be local or willing to re-locate to the Kansas City metro area.

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.
• Demonstrated project leadership skills

Top Benefits/Perks:

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

Vantage MedTech values a diverse team and is an Equal Opportunity Employer. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. All applicants must be authorized for full-time employment in the United States. For more information, visit www.vantagemedtech.com

No third-party candidates please.