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Systems Engineer Medical Devices Jobs (NOW HIRING)

RESOLVEM USA

Medical Devices System Engineer

Irvine, CA · On-site

$110K - $150K/yr

In this role, you will learn new technologies and lead technical teams to develop systems that ... engineering practice including technology or product development responsibility in medical devices ...

RESOLVEM USA

Medical Devices System Engineer

Irvine, CA · On-site

$110K - $150K/yr

In this role, you will learn new technologies and lead technical teams to develop systems that ... engineering practice including technology or product development responsibility in medical devices ...

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$53.5K

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

As of Jun 7, 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.

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.

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 May 2026, with employment types broken down into 1% As Needed, 28% Full Time, 69% Part Time, 1% Contract, and 1% Nights. Highlights an 95% Physical, 1% Hybrid, and 4% Remote job distribution, with an average salary of $127,215 per year, or $61.2 per hour.

Senior Validation Engineer - Medical Devices

Stark Pharma Solutions Inc

Silver Spring, MD • On-site

Contractor

Posted 3 days ago

Job description

Job Title: Senior Validation Engineer – Medical Devices

Location: Silver Spring, MD (Onsite)

Duration: 06 months contract (High potential for extension)

Job Summary

We are seeking a Senior Validation Engineer to support equipment lifecycle management, facility changes, and commercialization activities within a medical device environment. This role will play a key part in ensuring equipment and systems are validated, compliant, and maintained in a validated state throughout their lifecycle.

The ideal candidate will have strong experience in validation documentation, equipment qualification, and cross-functional collaboration within regulated environments.

Key Responsibilities

Validation & Documentation

  • Develop, review, and execute validation documents including:
    • User Requirement Specifications (URS)
    • Validation Determination Assessments (VDA)
    • Installation, Operational, and Performance Qualifications (IQ/OQ/PQ)
    • Requirements Traceability Matrix (RTM)
    • Final/Summary Reports
  • Support equipment lifecycle validation activities for commercial medical device operations
  • Execute validation protocols and ensure compliance with regulatory standards

Required Qualifications

  • Minimum 5+ years of experience in validation within medical device or regulated environments
  • Strong experience with equipment lifecycle management and validation documentation
  • Hands-on experience with IQ/OQ/PQ, URS, RTM, and validation reporting
  • Experience supporting commercialization, facility changes, or system transitions
  • Knowledge of GMP, FDA, and quality system requirements
  • Strong collaboration, communication, and problem-solving skills