Senior Systems Engineer

Proven; Olathe (KS); On-site; USD 110,000 - 160,000; Full time

Job summary

Proven is seeking a Senior Systems Engineer to lead cross-functional teams in the development of electromechanical and embedded medical devices. You will guide requirements, architecture, verification, and design controls from concept through commercialization, including manufacturing transfer.

The role requires 8–10 years in EM/embedded systems, expertise in medical device quality systems, and strong leadership to mentor junior engineers and collaborate with clients and stakeholders.

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 (ISO 13485/14971).
• Experience with requirements, design controls, and regulatory documentation.

Responsibilities

• Lead systems engineering activities from requirements to product design for medical device projects.
• Collaborate with software, electrical, mechanical, manufacturing, and test engineers.
• Develop system-level specifications aligned with business and technical goals.
• Create verification/validation strategies, test plans, and reports.
• Ensure design control compliance and risk management throughout the lifecycle.
• Support manufacturing transfer and production readiness.
• Mentor junior engineers and drive best practices.

Skills

Electromechanical systems

Embedded systems

Requirements management

Design control

Verification and validation

Risk management

Regulatory compliance

Education

Bachelor’s degree in mechanical, electrical or related engineering

Tools

Source Code Management

Requirements Management

Defect Tracking systems

Job description

Proven is hiring a Senior Systems Engineer on behalf of our client, an industry innovator in comprehensive design and manufacturing services for cutting-edge medical technologies. Supporting the advancement of healthcare solutions from initial concept to full product realization, our client develops and manufactures critical devices used in treating heart failure, cancer, stroke, gene therapy, and other complex medical conditions.

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.

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