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Systems Engineer Medical Devices information

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$53.5K

$127.2K

$167K

How much do systems engineer medical devices jobs pay per year?

As of Aug 31, 2026, the average yearly pay for systems engineer medical devices in the United States is $127,215.00, according to ZipRecruiter salary data. Most workers in this role earn between $98,000.00 and $157,000.00 per year, depending on experience, location, and employer.

What does a systems engineer do in medical devices?

A Systems Engineer in the medical devices industry is responsible for designing, integrating, and managing complex medical equipment and systems. They ensure that all components of a medical device work together safely and effectively, meeting regulatory and quality standards. Their role involves collaborating with multidisciplinary teams, overseeing requirements gathering, testing, risk management, and supporting the product lifecycle from conception to market release. Systems Engineers play a crucial part in ensuring that medical devices are reliable, safe, and compliant with industry regulations.

How does a systems engineer in medical devices typically collaborate with cross-functional teams during product development?

As a Systems Engineer in the medical device industry, you play a central role in bridging technical and non-technical teams throughout the product development lifecycle. You'll frequently collaborate with software, hardware, quality assurance, and regulatory teams to ensure that all system components integrate seamlessly and meet safety and compliance standards. Regular communication and documentation are essential, as you'll help translate clinical requirements into technical specifications and facilitate design reviews. This collaborative approach not only ensures product reliability but also helps you develop a broad understanding of the industry, supporting career advancement into leadership or specialized technical roles.

What are the key skills and qualifications needed to thrive as a systems engineer in medical devices, and why are they important?

To thrive as a Systems Engineer in Medical Devices, you need a solid background in engineering principles, systems integration, and regulatory compliance, usually supported by a degree in biomedical, electrical, or systems engineering. Familiarity with tools such as MATLAB, Simulink, requirements management systems, and certification in standards like ISO 13485 or IEC 62304 is highly beneficial. Strong problem-solving, communication, and project management skills help you collaborate effectively with multidisciplinary teams and stakeholders. These competencies ensure the safe, efficient, and compliant development of medical devices that meet both user needs and regulatory requirements.

What is the difference between Systems Engineer Medical Devices vs Biomedical Engineer?

AspectSystems Engineer Medical DevicesBiomedical Engineer
Required CredentialsBachelor's in Engineering, certifications like Certified Systems Engineering Professional (CSEP)Bachelor's or Master's in Biomedical Engineering or related field, professional engineering license often preferred
Work EnvironmentDesign, develop, and test medical device systems in R&D or manufacturing settingsResearch, develop, and improve medical devices and healthcare technologies, often in labs or clinical settings
Employer & Industry UsageMedical device companies, healthcare technology firms, regulatory agenciesHospitals, research institutions, medical device manufacturers, biotech firms
Common Search & ComparisonYesYes

While both roles focus on medical technology, Systems Engineer Medical Devices primarily concentrates on designing and integrating complex device systems, whereas Biomedical Engineers focus on developing and improving medical devices and healthcare solutions. The roles often overlap in industry and credentials but differ in daily responsibilities and work environments.

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Systems Engineer Medical Devices jobs near you
Infographic showing various Systems Engineer Medical Devices job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 92% Physical, 1% Hybrid, and 7% Remote job distribution, with an average salary of $127,215 per year, or $61.2 per hour.

Principal Systems Engineer - Medical Devices

Stark Pharma Solutions Inc

Bellevue, WA • On-site

Contractor

Re-posted 15 days ago

Job description

Job Title: Principal Systems Engineer - Medical Devices

Location: Bellevue, WA (Hybrid – Flexible Remote/Onsite Schedule)

Contract Duration: 12 Months

Work Schedule: Standard hours 8:00 AM – 5:00 PM (flexibility required based on project needs)

Job Summary

We are seeking a Principal Systems Engineer to support the development and integration of connected medical device technologies within a hybrid hardware/software ecosystem. This role will focus on system integration, verification & validation, data reliability, and end-to-end product performance across wearable devices, mobile applications, cloud platforms, and digital health systems.

The ideal candidate will have strong experience in systems engineering for connected medical devices, with expertise in integrated hardware/software environments, risk management, and product lifecycle development within regulated industries.

Key Responsibilities

  • Lead integration planning and testing activities across wearable devices, mobile applications, cloud software, algorithms, and user-facing platforms
  • Develop and execute system-level Verification & Validation (V&V) strategies, protocols, and reports
  • Perform systems modeling, hazard analysis, risk mitigation, and reliability assessments
  • Analyze system performance, data flow, integrity, and reliability across end-to-end data pipelines
  • Collaborate cross-functionally with Hardware, Software, Cloud, Quality, and Regulatory teams throughout product development
  • Support system troubleshooting, debugging, and root cause analysis related to hardware/software integration issues
  • Contribute to design reviews, technical documentation, compliance activities, and engineering best practices
  • Apply systems engineering methodologies and product development standards within regulated medical device environments

Required Qualifications

Bachelor’s or Master’s degree in:

  • Electrical Engineering
  • Biomedical Engineering
  • Computer Engineering
  • Systems Engineering
  • Related technical discipline
  • 5–8+ years of Systems Engineering experience supporting:
  • Connected medical devices
  • Hardware/software integrated systems
  • Digital health or end-to-end product ecosystems