Senior System Engineer

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

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

As a team member at Vantage MedTech, you’ll enjoy:

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