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Medical Device Systems Engineer Jobs (NOW HIRING)

Lead end-to-end design, development, and evaluation of complex medical device systems * Apply advanced engineering principles; mentor team members on best practices * Translate user needs into system ...

Lead end-to-end design, development, and evaluation of complex medical device systems * Apply advanced engineering principles; mentor team members on best practices * Translate user needs into system ...

... medical device systems. This role involves manual, automated, and integration testing, ensuring ... The ideal candidate will collaborate cross-functionally with engineering teams to develop and ...

Job Title: R&D Engineer III Duration:12 Months Location: Hybrid in Arden Hills, MN Shift: Business ... PM) About This Role Responsible for system level design of complex implantable medical device ...

Experience in medical device industry (preferred). * Experience with configuring and ... system. * Functional/working knowledge of AC/DC circuits. Technical report writing experience.

Medical Device Assembler

Madison, WI ยท On-site

$23 - $24/hr

Ensure work is completed in compliance with company quality system and medical device regulations ... Engineering group as required. Working Conditions: Clean, temperature controlled environment.

Experience in medical device industry (preferred). * Experience with configuring and ... system. * Functional/working knowledge of AC/DC circuits. Technical report writing experience.

Experience in medical device industry (preferred). * Experience with configuring and ... system. * Functional/working knowledge of AC/DC circuits. Technical report writing experience.

Experience in medical device industry (preferred). * Experience with configuring and ... system. * Functional/working knowledge of AC/DC circuits. Technical report writing experience.

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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 Jun 13, 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 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.

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 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.
More about Medical Device Systems Engineer jobs

Senior Software Engineer

Enterra Medical, Inc.

Saint Louis Park, MN โ€ข On-site

$150K - $165K/yr

Full-time

Posted 19 days ago


Job description

Senior Software Engineer
St. Louis Park, MN
Job Summary:
We are seeking a Senior Software Engineer with specialized experience in developing software for active implantable medical device systems. This role involves creating robust, secure, and scalable programming software and mobile applications that interface with implantable devices. The ideal candidate will have experience in medical device development, system integration, and regulatory compliance, with a passion for building technology that improves patient outcomes.
Responsibilities:
  • Design, develop, and maintain programmer software for medical device systems, including embedded components and mobile apps (iOS/Android).
  • Build secure and user-friendly mobile applications for clinicians and patients to monitor and interact with implantable devices.
  • Collaborate with cross-functional teams-hardware engineers, firmware developers, and clinical specialists-to ensure seamless integration between device, software, and external systems.
  • Implement secure communication protocols (e.g., Bluetooth Low Energy, proprietary RF) for data exchange between implantable devices and mobile apps.
  • Ensure adherence to medical device standards such as ISO 13485, IEC 62304, and FDA regulations throughout the software lifecycle.
  • Optimize software for performance, reliability, and cybersecurity in a highly regulated environment.
  • Conduct risk analysis, debugging, and verification to ensure software meets safety and efficacy requirements. Document design specifications, test plans, and validation reports per regulatory requirements.
  • Support clinical trials and post-market activities by analyzing system performance and deploying software updates.
  • Apply AI-based techniques for code development and process improvement, including automated code generation and intelligent code review.
Required Qualifications:
  • Bachelor's or Master's degree in Computer Science or Computer Engineering, or a related field.
  • 5+ years of experience developing software for medical devices or regulated systems.
  • Strong proficiency in programming languages such as C/C++, C#, Python, Java, or Swift/Kotlin for mobile development.
  • Experience with embedded systems and real-time operating systems (RTOS) as well as application-level development.
  • Familiarity with medical device regulations (FDA, ISO 13485, IEC 62304).
  • Hands-on experience with wireless communication protocols (BLE) and secure data transfer.
  • Experience with software development tools (GitHub, Jira) and automated testing frameworks.
Preferred Qualifications:
  • Experience with mobile app development for healthcare applications.
  • Familiarity with Agile development methodologies.
  • Knowledge of battery management systems and low-power optimization for connected devices.

Total Compensation: $150,000-165,000 DOE