Systems Engineer - Medical DevicesJob

Technical Leadership Product Requirements Systems Architecture Mechanical Engineering Electrical Engineering New Product Development Manufacturing Processes Artificial Intelligence Regulatory Requirements Requirements Management Engineering Documentation Requirements Traceability Quality Management Systems Engineering Design Process Medical Device Development Verification And Validation Troubleshooting (Problem Solving), This role leads end-to-end systems engineering for complex electromechanical and embedded medical devices, driving requirements development, system architecture, and product design from concept through commercialization. You collaborate closely with cross-functional engineering and clinical teams, ensure compliance with stringent quality and regulatory standards, and play a key role in bringing innovative medical technologies to market where you can see the products released to the public. Responsibilities

• Lead systems engineering activities for medical device projects, including requirements development, system architecture definition, and product design for electromechanical and embedded systems.
• 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 clear system-level specifications that align with business and technical objectives.
• Develop and execute verification and validation strategies, including detailed test plans, procedures, protocols, and reports.
• Maintain robust requirements traceability and ensure compliance with design control, quality system, and regulatory requirements.
• Troubleshoot and resolve complex system, hardware, software, and product design issues to support successful project execution.
• Participate in risk management activities, including risk assessments, design reviews, and phase gate reviews to ensure product safety, performance, and compliance.
• Support product development from concept through commercialization, including manufacturing transfer and ongoing production support activities.
• Provide technical leadership, mentoring, and guidance to junior engineers while promoting engineering best practices and continuous process improvement.
• Partner with project managers, clients, clinicians, and other stakeholders to deliver innovative solutions on schedule and within budget.
• Prepare high-quality written reports, test protocols, and engineering documentation to support the testing and verification of medical devices.
• Apply knowledge of relevant standards and regulations to guide design decisions and ensure regulatory compliance.
• Utilize Source Code Management, Requirements Management, and Defect Tracking systems to manage product development artifacts and ensure traceability.
• Contribute to the planning and execution of white box and automated testing strategies for embedded medical device systems., This position is based onsite in Olathe, KS, working standard office hours in a collaborative engineering environment. You will partner closely with a local team of approximately three to four Systems Engineers and regularly interact with an additional team of about four engineers located in New Jersey. The setting is a professional office within a medical device development organization, with access to modern engineering tools, documentation systems, and test environments that support electromechanical and embedded systems work. After approximately six months, there is an opportunity to transition to a hybrid work arrangement that combines onsite collaboration with remote flexibility, while maintaining strong communication and alignment with cross-functional teams., Technical Leadership Product Requirements Systems Architecture Mechanical Engineering Electrical Engineering New Product Development Manufacturing Processes Artificial Intelligence Regulatory Requirements Requirements Management Engineering Documentation Requirements Traceability Quality Management Systems Engineering Design Process Medical Device Development Verification And Validation Troubleshooting (Problem Solving) +0

Planning Firmware Visionary Leadership Mentorship Innovation End Systems Coordinating Communication Test Planning Risk Analysis Product Design Risk Management Version Control Test Automation Problem Solving Medical Devices Defect Tracking Safety Standards Embedded Systems Test Engineering Commercialization Health Technology White-Box Testing ISO/IEC Standards Project Management, * Bachelor’s degree in mechanical engineering, electrical engineering, or a related engineering field.

• 8-10 years of professional experience in electromechanical and embedded systems product development.
• Hands-on experience with medical device development under formal quality systems.
• Strong background in systems engineering, including requirements development, system architecture, and product design.
• Proficiency in collaborating with software, electrical, mechanical, manufacturing, process, and test engineering teams.
• Experience with Source Code Management tools for software and firmware development.
• Experience with Requirements Management systems to capture, track, and maintain system requirements.
• Experience with Defect Tracking systems to manage and resolve issues throughout the development lifecycle.
• Proven ability to develop and execute verification and validation test plans, procedures, protocols, and reports for medical devices.
• Experience conducting white box testing and implementing automated testing approaches for embedded systems.
• Experience working with FDA Class II or Class III medical device regulatory requirements, or in a similar regulated product development environment.
• Advanced knowledge of relevant standards and regulations, including ISO standards, 93/42/EEC, 90/385/EEC, EN45502, EN60601-1, and EN61000.
• Demonstrated project leadership skills, including leading engineering activities and coordinating cross-functional teams.
• Strong analytical and problem-solving skills for troubleshooting complex system, hardware, and software issues.
• Excellent written communication skills for producing clear reports, test documentation, and engineering records., * Experience using tools such as Jira or similar platforms for defect tracking and project collaboration.
• background in electrical engineering and embedded systems design in addition to systems engineering expertise.
• Experience participating in risk management, design reviews, and phase gate processes within a regulated environment.
• Ability to mentor and coach junior engineers, fostering a culture of technical excellence and continuous improvement.
• Comfort working closely with clinicians and external stakeholders to translate user needs into system requirements.
• Interest in seeing medical device products progress from concept to public release and real-world use., Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors., Lenexa, KS*Hybrid

JIRA Planning Firmware Visionary Leadership Mentorship Innovation End Systems Coordinating Communication Test Planning Risk Analysis Product Design Risk Management Version Control Test Automation Problem Solving Medical Devices Defect Tracking Safety Standards Embedded Systems Test Engineering Commercialization Health Technology White-Box Testing ISO/IEC Standards Project Management

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