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Systems Engineer Medical Devices Jobs (NOW HIRING)

Intellectt INC

Systems Engineer

New Kensington, PA · On-site

Medical Devices / Healthcare Technology We are actively hiring a Systems Engineer in the Medical Devices / Healthcare Technology industry. This is an excellent opportunity for professionals with ...

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Quality Engineer: Medical Devices

San Francisco, CA · On-site

$84K - $109K/yr

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential ...

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Quality Engineer: Medical Devices

San Francisco, CA · On-site

$84K - $109K/yr

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential ...

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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 Jul 1, 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 the medical devices industry?

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.

Is BME a stressful job?

Systems engineers in medical devices often face stress related to ensuring device safety, regulatory compliance, and tight project deadlines. The role requires attention to detail, problem-solving skills, and sometimes working under pressure to meet clinical and industry standards.

What engineers make $300,000 a year?

Senior systems engineers in specialized fields such as medical devices, aerospace, or software engineering can earn $300,000 or more annually, especially with extensive experience, advanced certifications, and leadership roles. High compensation often involves managing complex projects, working in high-demand industries, or holding executive-level responsibilities.

What engineer makes $500,000 a year?

Highly experienced systems engineers in specialized fields such as medical devices, aerospace, or software engineering can earn $500,000 or more annually, often through a combination of base salary, bonuses, and stock options. Achieving this level typically requires advanced skills, extensive experience, and often leadership or executive responsibilities.

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.

What does a systems engineer do in medical devices?

A systems engineer in medical devices designs, develops, and integrates complex hardware and software systems to ensure device safety, functionality, and compliance with regulatory standards. They often collaborate with cross-disciplinary teams, perform risk assessments, and use tools like CAD and simulation software to optimize device performance throughout the product lifecycle.
More about Systems Engineer Medical Devices jobs
What cities are hiring for Systems Engineer Medical Devices jobs? Cities with the most Systems Engineer Medical Devices job openings:
What job categories do people searching Systems Engineer Medical Devices jobs look for? The top searched job categories for Systems Engineer Medical Devices jobs are:
Systems Engineer Medical Devices jobs near you
Infographic showing various Systems Engineer Medical Devices job openings in the United States as of June 2026, with employment types broken down into 1% As Needed, 82% Full Time, and 17% Part Time. Highlights an 91% Physical, 2% Hybrid, and 7% Remote job distribution, with an average salary of $127,215 per year, or $61.2 per hour.
Reliability & Validation Engineer (Medical Devices) - Hybrid

Reliability & Validation Engineer (Medical Devices) - Hybrid

DivIHN Integration Inc

Deerfield, IL • On-site

Other

Posted 3 days ago

Job description

For further inquiries regarding the following opportunity, please contact our Talent Specialist
Kunal at 224-704-1709

Title: Reliability & Validation Engineer (Medical Devices) - Hybrid
Location: Deerfield, IL
Duration: 10 Months
Description:
Job Summary
We are seeking a Reliability Performance Engineer to develop and execute testing documentation and scripts that validate and verify both physical and digital Client's medical products. This role will be responsible for designing, implementing, and managing test protocols that ensure product reliability, security, and performance under various conditions, including high-volume simulations, network interactions, and cybersecurity challenges. The ideal candidate has a strong background in test automation, system validation, and compliance-driven testing within the medical device industry.
Key Responsibilities
Test Development & Execution
Create detailed test plans, scripts, and protocols to validate software, firmware, and hardware components of Client's medical devices.
Develop and automate tests that simulate high-volume data processing, real-world network interactions, and security threats.
Conduct functional, integration, and system-level testing to ensure compliance with regulatory and industry standards.
Perform manual and automated testing for both digital (software-based) and physical (hardware-based) products.
Simulation & Performance Testing
Design and execute high-volume simulations to evaluate device performance under extreme workloads.
Validate network reliability by simulating real-world connectivity scenarios, including cloud, IoT, and hospital network environments.
Conduct cybersecurity testing, including penetration testing, encryption validation, and threat modeling.
Data Analysis & Reporting
Analyze test results, identify failure points, and collaborate with R&D, engineering, and security teams for issue resolution.
Document testing methodologies, defects, and performance metrics in compliance with FDA, ISO 13485, IEC 62304, and HIPAA regulations.
Support root cause analysis (RCA) and corrective/preventive actions (CAPA) based on test findings.
Collaboration & Continuous Improvement
Work closely with software developers, network engineers, and product designers to refine product testing approaches.
Develop and maintain automated test frameworks for continuous integration/continuous deployment (CI/CD).
Stay updated on medical device regulations, cybersecurity best practices, and emerging testing technologies.
Qualifications & Skills
Required:
Bachelor's or Master's degree in Computer Science, Electrical Engineering, Biomedical Engineering, or related field.
years of experience in software/hardware testing, automation, or medical device validation.
Strong knowledge of test scripting languages (Python, Java, C#, or similar).
Experience with test management tools (e.g., TestRail, JIRA, Selenium, Appium, Cypress).
Familiarity with network protocols, security testing, and performance benchmarking.
Understanding of FDA 21 CFR Part 820, ISO 14971 (Risk Management), and IEC 60601 standards.
Preferred:
Experience with cloud-based medical device testing (AWS, Azure, IoT platforms).
Knowledge of cybersecurity frameworks (NIST, OWASP, FIPS 140-2).
Certification in ISTQB, CISSP, or Certified Ethical Hacker (CEH).

About us:
DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.