Job Summary We are seeking an experienced Senior Systems Engineer to lead the development of complex electromechanical and embedded medical device systems. The ideal candidate will have strong experience across both hardware and software aspects of product development, including embedded, real-time, PC, Linux, and Windows applications. The Senior Systems Engineer will collaborate with cross-functional engineering teams throughout the complete product development lifecycle—from requirements management and system architecture through verification, validation, commercialization, and manufacturing transfer. This role also provides technical leadership, mentorship, and guidance to junior engineers. Candidates must be local to the Kansas City metro area or willing to relocate to the area. This is an onsite position and is not remote. Key Responsibilities Lead systems engineering activities, including requirements development, system architecture, and product design. Collaborate with software, electrical, mechanical, manufacturing, process, and test engineering teams throughout the product lifecycle. Analyze customer and product requirements and develop system-level specifications. 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. Participate in risk management activities, design reviews, and phase-gate reviews. Support product development from concept through commercialization, manufacturing transfer, and production. Mentor junior engineers and promote engineering best practices and process improvements. Collaborate with project managers, clients, clinicians, and other stakeholders to deliver projects on schedule and within budget. Provide technical leadership and guidance across multidisciplinary engineering teams. Education & Experience Bachelor's degree in Mechanical Engineering, Electrical Engineering, Systems Engineering, or a related engineering discipline. 8-10+ years of professional experience in electromechanical and embedded systems product development. Experience developing medical devices within established quality systems. Experience with Source Code Management, Requirements Management, and Defect Tracking systems. Experience preparing engineering documentation, written reports, test protocols, and verification/validation documentation for medical devices. Experience with white-box testing and automated testing . Experience with FDA Class II or Class III medical device regulatory requirements or a comparable regulated product development environment. Advanced knowledge of relevant medical device standards, including

ISO 13485, ISO 14971, 93/42/EEC, 90/385/EEC, EN 45502, EN

60601-1, and

EN 61000

. Demonstrated project leadership and cross-functional collaboration skills. Strong communication, analytical, troubleshooting, and technical documentation skills. Core Competencies Systems Engineering Requirements Management System Architecture Electromechanical Systems Embedded & Real-Time Systems Verification & Validation Risk Management Design Controls Medical Device Development Regulatory Compliance Requirements Traceability Automated & White-Box Testing Cross-Functional Leadership Technical Mentoring Work Location Olathe, KS - Onsite Candidates must be local to the Kansas City metro area or willing to relocate. Employment Requirements Candidates must be authorized to work full-time in the United States.

Pay:

$100,000.00 - $120,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Paid time off Retirement plan Vision insurance

Work Location:

In person