Hybrid Principal Systems Engineer, Medical Devices

Medela; Illinois; Hybrid; USD 140,000 - 180,000; Full time

Benefits offered by this job

401K with match

Pension Plan

A great place to work!

Job summary

Medela LLC in McHenry, IL seeks a Principal Systems Engineer to lead system architectures for complex electromechanical medical devices across maternity and NICU portfolios. You will translate needs into measurable requirements, develop interfaces, and guide cross-functional teams through product development with emphasis on regulatory alignment.

You will engage with hardware, software, and connected technologies, collaborating with engineers to resolve integration challenges and establish

Qualifications

• 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

Skills

Systems architecture

Requirements development

Embedded software

Hardware-software integration

Regulatory standards knowledge

MBSE / SysML

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in Systems/Electrical/Mechanical/Biomedical Engineering or related

Tools

SysML

MBSE

APIs

ICDs

Job description

Medela LLC in McHenry, IL seeks a Principal Systems Engineer to lead system architectures for complex electromechanical medical devices across maternity and NICU portfolios. You will translate needs into measurable requirements, develop interfaces, and guide cross-functional teams through product development with emphasis on regulatory alignment.

You will engage with hardware, software, and connected technologies, collaborating with engineers to resolve integration challenges and establish