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Medical Device Systems Engineer Jobs (NOW HIRING)

Enovis

Systems Engineer

Austin, TX

Systems Engineer Location: Austin, Texas Job Title/High Level Position Summary: We are seeking a ... medical device standards and regulatory requirements Identify, troubleshoot, and resolve system ...

Cedarparktexasedc

Systems Engineer

Austin, TX · On-site

$120 - $160/hr

Experience in medical device systems engineering or regulated environments (FDA/ISO) * Experience with surgical navigation platforms * Understanding of anatomy and biomechanics in orthopedic ...

Enovis Corporation

$110 - $140/hr

Experience in medical device systems engineering or regulated environments (FDA/ISO) * Experience with surgical navigation platforms * Understanding of anatomy and biomechanics in orthopedic ...

New

Enovis Corporation

Systems Engineer

Austin, TX · On-site

$110 - $140/hr

Experience in medical device systems engineering or regulated environments (FDA/ISO) * Experience with surgical navigation platforms * Understanding of anatomy and biomechanics in orthopedic ...

New

Medtronic

Sr. Software Systems Engineer

Fridley, MN · On-site

The Senior Software Systems Engineer on the Neuromodulation and Pelvic Health Pre-Market Design ... Provide design quality support for software and software-enabled medical device development ...

Enovis

Systems Engineer

Austin, TX · On-site

... medical device standards and regulatory requirements • Identify, troubleshoot, and resolve system-level issues across integrated hardware/software environments • Document system architecture ...

Medtronic

Sr. Software Systems Engineer

Fridley, MN · On-site

The Senior Software Systems Engineer on the Neuromodulation and Pelvic Health Pre-Market Design ... Provide design quality support for software and software-enabled medical device development ...

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Medical Device Systems Engineer information

See salary details

$53.5K

$127.2K

$167K

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

As of Sep 6, 2026, the average yearly pay for medical device systems engineer 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 medical device systems engineer do?

A Medical Device Systems Engineer is responsible for designing, developing, and integrating complex medical devices and systems. They work closely with multidisciplinary teams to ensure that devices meet regulatory standards, are safe for patients, and function as intended. Their role often includes system architecture, requirements analysis, risk management, and verification and validation testing. They also collaborate with clinicians and regulatory bodies to ensure compliance with healthcare standards. Overall, their work is crucial in bringing innovative medical technologies from concept to market.

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

Medical Device Systems Engineers play a central role in coordinating with interdisciplinary teams such as mechanical, electrical, software, and quality assurance engineers, as well as regulatory and clinical experts. They are responsible for integrating various subsystems, ensuring the final device meets both technical and regulatory requirements. This often involves leading design reviews, facilitating communication between specialties, and translating user needs into system specifications. Collaboration is key, as engineers must address feedback from multiple stakeholders and ensure seamless system integration throughout the product development lifecycle.

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

To thrive as a Medical Device Systems Engineer, you need a strong background in biomedical engineering, systems engineering principles, and regulatory knowledge, often supported by a relevant engineering degree. Familiarity with CAD software, embedded systems, FDA/ISO standards, and risk management tools is typically required. Exceptional problem-solving skills, attention to detail, and effective communication are vital soft skills for this role. These competencies ensure the safe and efficient design of medical devices that meet regulatory requirements and patient safety standards.

What is the difference between Medical Device Systems Engineer vs Medical Device Quality Engineer?

AspectMedical Device Systems EngineerMedical Device Quality Engineer
Required CredentialsBachelor's in Engineering, Systems Engineering certificationsBachelor's in Engineering, Quality Management certifications (e.g., ISO 13485)
Work EnvironmentDesign, develop, and integrate medical device systemsEnsure product quality, compliance, and risk management
Employer & Industry UsageMedical device manufacturers, R&D teamsRegulatory agencies, manufacturing firms, compliance departments
Common Search & ComparisonFocus on system integration and designFocus on quality assurance and compliance

The Medical Device Systems Engineer primarily focuses on designing and integrating medical device systems, ensuring functionality and performance. In contrast, the Medical Device Quality Engineer concentrates on maintaining product quality, regulatory compliance, and risk management. Both roles are essential in the medical device industry but serve different aspects of product development and manufacturing.

More about Medical Device Systems Engineer jobs

What job categories do people searching Medical Device Systems Engineer jobs look for?

The top searched job categories for Medical Device Systems Engineer jobs are:

Medical Device Systems Engineer jobs near you
Infographic showing various Medical Device Systems Engineer 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.

Systems Engineer III-Product Development

1 point system

Bellevue, WA • On-site

Contractor

Re-posted 21 days ago

Job description

Interview: 1st round MS Teams and 2nd round in-person/onsite

 

We are currently seeking a Principal Systems Engineer to join the R&D team at our Bellevue office. In this role, you will be responsible for driving the development and integration of complex, end-to-end medical device systems that involve wearable devices with sensors, mobile applications, software algorithms, cloud software applications, user portals and gateways, and data pipelines. You will apply systems engineering principles throughout the entire product lifecycle, focusing on verification and validation.

What you'll be doing:
• Evaluate system integration points and lead the team in integration planning and testing between wearable devices, mobile applications, software algorithms, cloud software applications, and user portals.
• Develop and execute comprehensive test plans to verify and validate system performance, safety, and security across the entire end-to-end ecosystem, including test protocol and report write-up.
• Develop comprehensive system models, risk analyses, and mitigation strategies, addressing the unique challenges of each component in the end-to-end system.
• Work with development engineers to analyze system performance, reliability, and data integrity across the entire data pipeline, from wearable device data collection to cloud storage and processing.
• Act as a subject matter expert for project teams in applying systems engineering standards and best practices to the Product Development process.

What you'll bring:
• Demonstrated success in leading the development of end-to-end systems, ideally in the medical device or healthcare industry.
• Proven expertise in systems modeling, requirements management, risk analysis, verification, and validation.
• Strong understanding of medical device regulations, quality systems, and data privacy regulations.
• Broad technical knowledge encompassing hardware (such as embedded systems and sensors), software (such as algorithms, cloud and mobile applications), and data engineering.
• Experience in requirements management, validation, and verification practices.
• Experience in developing system design verification and validation plans and functional test procedures.
• Demonstrated ability to work across disciplines to build consensus and drive complex systems to completion.
• Critical thinking and problem-solving skills.
• An autonomous self-starter personality with a culture of collaboration.
• Detail oriented with strong organization and time management skills and the ability to multi-task across a diverse scope of responsibilities, projects, and people.
• Effective verbal and written communication skills and the ability to facilitate and work effectively in diverse, multi-functional teams.

Required Background
• Bachelor’s or Master’s degree in Electrical Engineering, Biomedical Engineering, Computer Engineering, Systems Engineering, or other technical or science disciplines.
• 5 – 8+ years of experience in systems engineering, with a significant focus on connected medical devices or other complex, end-to-end systems involving hardware and software integration.
• Intermediate knowledge of electro-mechanical hardware qualification and statistics. Knowledge of CAD is a plus.
• Experience in automation and programming/scripting (Python, RESTful API). Familiarity with Azure DevOps (ADO) or similar CI/CD tools is a plus.
• Debugging skills – ability to trace and resolve hardware and software issues.
• Familiarity with design/version control and requirement tool is a plus,

Note from the hiring manager.

Role: System Engineer — product-development side.

Location: Bellevue, WA (on-site or hybrid as applicable).

Domain: Engineering background required; regulated industry (medical device preferred) or similar regulated environment required.

Key responsibilities: requirements-driven system engineering for product development, verification & validation, test automation, debugging, integration testing, writing test protocols and automated test scripts, participation in CI/CD (Azure DevOps).

Verification & Validation (V&V)

Experience designing test protocols and test plans

Experience with integration testing

Non-IT engineering background

Must-have checklist (mark Y/N)

Engineering degree:

Regulated industry:

V&V:

Test automation:

Debugging tools:

Azure DevOps & CI/CD:

Systems engineering (product dev)

ADO is highly preferred.

Interview: 1st round MS Teams and 2nd round in-person/onsite