Principal Medical Device Systems Engineer - Hybrid

Medela; McHenry (IL); Hybrid; USD 119,000 - 161,000; Full time

Benefits offered by this job

Benefits plan

401K match

Pension plan

Parental leave

Paid holidays

Great place to work

Job summary

Medela in McHenry, IL seeks a Principal Systems Engineer to provide hands‑on technical leadership for its medical device portfolio. You will drive system architectures, define interfaces and collaborate with mechanical, electrical and software teams to solve complex challenges across hardware, software and cloud platforms.

The ideal candidate will have extensive experience in electromechanical medical devices, strong MBSE proficiency, and a solid understanding of regulatory design controls and

Qualifications

• Bachelor’s degree in a related technical discipline.
• Extensive experience in complex electromechanical systems or connected medical technologies.
• Strong background in embedded software or software‑intensive electromechanical systems.
• Experience translating user needs into system requirements and developing system‑level architectures.
• Solid understanding of hardware/software integration and interfaces.
• Experience leading complex engineering initiatives and influencing multidisciplinary teams.
• Knowledge of FDA design controls, ISO 13485, ISO 14971 and IEC 60601.
• Experience with MBSE, SysML or related systems engineering tools.
• Experience developing medical devices for international markets.

Responsibilities

• Lead development of system architectures for complex electromechanical medical devices.
• Translate customer and clinical needs into measurable system requirements.
• Develop and maintain architectures, specifications and documentation across hardware, software and connected tech.
• Provide guidance on architectural decisions and complex engineering challenges.
• Collaborate with multidisciplinary engineers to resolve integration challenges.
• Define interfaces for communication with hospital networks and cloud platforms.
• Review verification and validation strategies to meet regulatory standards.
• Support risk management, design controls and regulatory submissions.
• Hands‑on involvement in product development lifecycle.

Skills

Systems engineering

Electrical engineering

Mechanical engineering

Embedded software

MBSE

SysML

Hardware-Software integration

Medical devices

Requirements development

Systems architecture

Education

Bachelor’s degree in Systems Engineering

Tools

MBSE

SysML

Job description

Medela in McHenry, IL seeks a Principal Systems Engineer to provide hands‑on technical leadership for its medical device portfolio. You will drive system architectures, define interfaces and collaborate with mechanical, electrical and software teams to solve complex challenges across hardware, software and cloud platforms.

The ideal candidate will have extensive experience in electromechanical medical devices, strong MBSE proficiency, and a solid understanding of regulatory design controls and