Principal Systems Engineer

Medela•McHenry, IL

40d•Hybrid

About The Position

Medela LLC, in McHenry, IL is seeking a Principal Systems Engineer to provide hands-on technical and architectural leadership for its Maternity Care and NICU product portfolio. This is an opportunity for a hands-on engineer who thrives on solving complex problems, influencing technical decisions and collaborating with talented engineering professionals. The ideal candidate brings strong experience in complex electromechanical medical devices, systems architecture and requirements development, along with an understanding of embedded software and connected device technologies. This is a highly collaborative, hands-on technical leadership position with the opportunity to influence product development across a diverse medical device portfolio.

Requirements

Bachelor's degree in Systems Engineering, Electrical Engineering, Mechanical Engineering, Biomedical Engineering or a related technical discipline.
Extensive experience developing complex electromechanical systems, diagnostic equipment, or connected medical technologies within the medical device industry.
Strong background in embedded software, firmware or software-intensive electromechanical systems.
Demonstrated experience translating user needs into system requirements and developing system-level architectures.
Strong understanding of hardware and software integration, system interfaces and technical requirements management.
Experience leading complex engineering initiatives and influencing multidisciplinary teams without direct reporting authority.
Hands-on experience developing technical specifications, resolving system integration challenges and supporting product development.
Solid understanding of verification and validation, risk management and regulated product development.
Experience defining interfaces between physical devices and external systems, including hospital networks and cloud platforms.
Familiarity with APIs, interface control documents (ICDs) and wireless communication technologies.
Working knowledge of FDA design controls, ISO 13485, ISO 14971 and IEC 60601.
Experience with model-based systems engineering (MBSE), SysML or related systems engineering tools.
Experience developing medical devices for international markets.

Responsibilities

Lead the development of system architectures for complex electromechanical medical devices, including new product development, existing product improvements and system integration initiatives.
Translate customer, clinical and business needs into clear, measurable system and subsystem requirements.
Develop and maintain system architectures, interface specifications and technical documentation across hardware, software and connected technologies.
Provide expertise with object-oriented development methodologies, networks, data storage, data modeling, data ontologies, wireless communication and security architectures.
Collaborate with mechanical, electrical and software engineers to evaluate technical alternatives, resolve integration challenges and establish effective engineering solutions.
Define interfaces that enable medical devices to communicate with external systems, including hospital networks and cloud-based platforms.
Serve as a principal technical resource, providing guidance on architectural decisions and resolving complex engineering challenges.
Partner with engineering leadership and cross-functional teams to establish technical direction and gain alignment on design decisions.
Review verification and validation strategies to ensure products meet system requirements, performance expectations and applicable regulatory standards.
Support risk management, design controls and technical documentation for regulatory submissions and audits.
Hands-on involvement in engineering activities throughout the product development lifecycle.
Provide technical oversight and guide engineering personnel in resolving varied technical/scientific problems with systems engineering principles