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Manager Medical Device Software Engineer Jobs in Illinois

Be involved in the medical device software design controls activities, in accordance with the FDA ... Support Change Management and Major Incidents (MI) processes, ensuring organizational compliance ...

Be involved in the medical device software design controls activities, in accordance with the FDA ... Support Change Management and Major Incidents (MI) processes, ensuring organizational compliance ...

We are a pioneer in developing innovative implantable medical device technologies and devices that ... Experience working with configuration management and defect tracking tools. * BS/MS Degree in ...

... days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance ... Evaluate and integrate relevant engineering advances for improving or solving problems Understand ...

Senior Software Engineer

Elgin, IL ยท On-site

$121K - $159K/yr

Manage assigned projects from start to finish; for major projects reports to Project Manager or ... A minimum of 4 years of relevant work experience in the medical device field or other highly ...

Lead specialized security testing and threat modeling for FDA-regulated medical device software ... engineering teams with hands-on remediation guidance. * Automate security testing by developing ...

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Manager Medical Device Software Engineer information

What are the key skills and qualifications needed to thrive as a manager medical device software engineer, and why are they important?

To thrive as a Manager Medical Device Software Engineer, you need expertise in software development, medical device regulations (such as FDA or ISO 13485), and a background in engineering or computer science, often supported by advanced degrees or certifications. Familiarity with tools like version control systems (e.g., Git), embedded systems platforms, and quality management software is essential, along with understanding regulatory documentation processes. Strong leadership, effective communication, and problem-solving abilities distinguish top performers in this role. These skills are crucial for ensuring safe, compliant, and innovative medical device software development while leading teams to deliver high-quality products.

How does a manager medical device software engineer typically collaborate with cross-functional teams during product development?

A Manager Medical Device Software Engineer frequently works alongside teams such as regulatory affairs, quality assurance, hardware engineering, clinical specialists, and marketing. They coordinate software development activities to ensure compliance with industry standards and regulatory requirements, while also aligning software features with clinical and business needs. These managers often lead design reviews, facilitate risk assessments, and ensure effective communication between software engineers and non-technical stakeholders. This collaborative environment is essential for delivering safe, effective, and user-friendly medical devices.

What does a manager medical device software engineer do?

A Manager Medical Device Software Engineer oversees teams that design, develop, and maintain software for medical devices. They ensure that the software complies with regulatory standards, works reliably, and meets the needs of healthcare professionals and patients. In addition to technical leadership, they coordinate with cross-functional teams, manage project timelines, and mentor engineers. Their role is critical in ensuring products are both safe and effective for use in medical settings.
What are the most commonly searched types of Medical Device Software Engineer jobs in Illinois? The most popular types of Medical Device Software Engineer jobs in Illinois are:
What job categories do people searching Manager Medical Device Software Engineer jobs in Illinois look for? The top searched job categories for Manager Medical Device Software Engineer jobs in Illinois are:
What cities in Illinois are hiring for Manager Medical Device Software Engineer jobs? Cities in Illinois with the most Manager Medical Device Software Engineer job openings:

Embedded Software Engineer - Medical Devices

Medela

Mchenry, IL โ€ข On-site

$105K/yr

Full-time

Retirement, PTO

Posted 9 days ago


Job description

Embedded Software Engineer - Medical Devices
Location: McHenry, IL (Hybrid - 3 days onsite)
Salary starting at $105,000 with bonus potential
Build software that helps improve the lives of mothers and babies.
At Medela, our mission is to turn science into care by developing innovative medical technology that supports families around the world. We're looking for an Embedded Software Engineer with experience developing firmware for embedded hardware in a regulated product development environment.
This is NOT an application, web, or enterprise software development position.
We are specifically seeking engineers with embedded firmware development experience and medical device (preferred) or other highly regulated industry experience.
What You'll Do
As an Embedded Software Engineer, you'll design and develop firmware for microcontroller-based medical devices while working closely with electrical, systems, manufacturing, quality, and regulatory engineering teams.
Responsibilities include:
  • Design, develop, test, and maintain embedded firmware in Embedded C/C++
  • Develop firmware for microcontroller-based connected medical devices
  • Create and maintain device drivers, hardware abstraction layers (HAL), bootloaders, diagnostics, and production test software
  • Support board bring-up, hardware/software integration, debugging, and troubleshooting
  • Work with RTOS and/or bare-metal embedded systems
  • Develop communication interfaces using protocols such as UART, SPI, I2C, CAN, BLE, Wi-Fi, MQTT, or similar
  • Participate in software architecture, requirements development, verification, risk controls, and traceability
  • Execute unit, integration, regression, and system testing
  • Support manufacturing, design transfer, production ramp-up, and post-market product maintenance
  • Ensure compliance with quality and regulatory requirements throughout the software development lifecycle

Required Qualifications
To be considered, candidates should have:
  • Bachelor's degree in Electrical Engineering, Computer Engineering, Computer Science, Embedded Systems Engineering, or a related technical discipline
  • 3+ years of embedded firmware development experience
  • Strong programming experience in Embedded C/C++
  • Experience developing firmware for embedded microcontrollers
  • Experience using embedded development tools, debuggers, and version control systems (Git, Azure DevOps, Jira, etc.)
  • Experience with communication protocols such as UART, SPI, I2C, CAN, BLE, Wi-Fi, or MQTT
  • Experience debugging embedded systems using JTAG/SWD debuggers, oscilloscopes, logic analyzers, or similar lab equipment
  • Experience working with RTOS or bare-metal embedded systems
  • Strong understanding of software lifecycle processes, testing, verification, and documentation

Important Candidate Requirements
Please apply only if you have experience with ALL of the following:
  • Embedded firmware development (not application or web software)
  • Embedded C/C++
  • Microcontroller-based products
  • Hardware/software integration and debugging
  • 3+ years of embedded software engineering experience

What Makes Someone Successful
You are:
  • A hands-on embedded engineer who enjoys working close to the hardware
  • Comfortable collaborating with electrical, systems, manufacturing, quality, and regulatory engineers
  • Detail-oriented with strong documentation skills
  • Passionate about building reliable, safety-focused products
  • Able to balance innovation with quality and regulatory compliance

Strongly Preferred
Medical device experience OR experience developing products in another regulated industry (aerospace, industrial controls, automotive safety systems, etc.)
Preferred Qualifications
We're especially interested in candidates who have experience with:
  • Medical device software development
  • Other highly regulated industries such as aerospace, automotive safety systems, industrial controls, or life sciences
  • IEC 62304 , ISO 13485, ISO 14971
  • Software traceability and Design History Files (DHF)
  • Secure firmware development and cybersecurity for connected devices

Why Join Medela?
You'll work on products that directly improve patient care while collaborating with a multidisciplinary engineering team dedicated to innovation, quality, and regulatory excellence. This is an opportunity to develop technology that makes a meaningful difference in the lives of families around the world.
  • Competitive Salary Starting Salary of $105,000 plus bonus
  • Comprehensive benefits plan
  • 401K with match
  • Money Purchase Retirement Plan
  • 16-week Paid Parental Leave
  • Generous PTO package
  • 14 paid holidays
  • A great place to work!

This is not a job description. More details will be provided regarding the functions of this position.
We are not accepting candidates from recruiting firms or agencies.
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.
Our employees are empowered to serve this purpose in a family-owned company that is growing rapidly around the world. We value intensive exchanges, diverse perspectives, and unbureaucratic decisions. You will have the opportunity to develop at an international level, and witness the direct impact your work has on our company's success.
If you are interested in this opportunity, we are looking forward to receiving your application.
For this position we only consider direct applications - thank you for your understanding.

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.
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