Hybrid Principal Systems Engineer - Medical Devices

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

Benefits offered by this job

Comprehensive benefits plan

401K with match

Pension Plan

Paid Parental Leave (16 weeks)

Generous PTO & holidays

Job summary

Medela is seeking a Principal Systems Engineer to lead architectures for complex electromechanical medical devices in McHenry, IL. You will translate clinical and customer needs into clear system requirements and design interfaces for external systems, hospital networks and cloud platforms.

This hands-on technical leadership role spans hardware, software and connected devices, MBSE and systems engineering tools.

Qualifications

• Bachelor’s degree in engineering or a related technical discipline.
• Extensive experience in complex electromechanical medical devices.
• Strong embedded software and firmware background.
• Proven ability to translate user needs into system requirements.
• Experience with MBSE, SysML and interface control documents.

Responsibilities

• Lead development of system architectures for complex electromechanical medical devices.
• Translate customer, clinical and business needs into clear system and subsystem requirements.
• Develop and maintain system architectures, interface specifications and technical documentation.
• Provide expertise with object-oriented development methodologies, networks, data storage and security architectures.
• Collaborate with mechanical, electrical and software engineers to resolve integration challenges.
• Define interfaces enabling communication with external systems, hospital networks and cloud platforms.
• Serve as a principal technical resource on architectural decisions and engineering challenges.
• Partner with leadership to establish technical direction and gain alignment on design decisions.
• Review verification and validation strategies to ensure regulatory compliance and performance.
• Support risk management, design controls and regulatory submissions.
• Hands-on involvement in engineering activities throughout the product lifecycle.
• Provide technical oversight and guide engineers in applying systems engineering principles.

Skills

Systems Architecture

Embedded Software

MBSE / SysML

Regulatory Knowledge

Interfaces & ICDs

Cross-functional Leadership

Education

Bachelor’s degree in engineering or related technical discipline

Tools

SysML

Job description

Medela is seeking a Principal Systems Engineer to lead architectures for complex electromechanical medical devices in McHenry, IL. You will translate clinical and customer needs into clear system requirements and design interfaces for external systems, hospital networks and cloud platforms.

This hands-on technical leadership role spans hardware, software and connected devices, MBSE and systems engineering tools.