Principal Systems Engineer

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

Principal Systems Engineer-Medical Devices

Location: McHenry, IL

Hybrid Work Schedule: Three days a week on-site in McHenry and two days from home office

Salary starting at $140K plus bonus

Are you an experienced hands-on Systems Engineer who enjoys solving complex technical challenges, developing innovative medical devices and bringing together multiple engineering disciplines to create successful products?

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.

What You’ll Do-Principal Systems Engineer, Medical Devices

• 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

Qualifications for the Principal System Engineer, Medical Devices

• 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.

What we offer our Principal Systems Engineer, Medical Devices

401K with match

Pension Plan

A great place to work!

At Medela, you will be joining a global community of colleagues, united by the purpose that drives our business: helping people. Medela exists to advance human health and well-being through knowledge-based and innovative human milk and medical vacuum solutions.

This is not a job description. More details will be provided regarding the functions of this position.

As an EEO/Affirmative Action Employer, all qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, citizenship, sex, protected veteran status, age, physical or mental disability, medical condition, HIV/AIDs status, marital status, domestic partner status, sexual orientation, gender identity (transgender status), weight, height or any other characteristic protected by federal, state, or local law or ordinance.