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Medical Device Software Testing Jobs in Boston, MA

Software Design Assurance Eng

Bedford, MA ยท On-site

$102.48 - $163.97/hr

Tracks and riskโ€‘assesses software anomalies for preโ€‘ and postโ€‘market medical device software. * Conducts detailed rootโ€‘cause analyses for software quality issues and validates key design ...

... in testing processes, efficiency, and integration within Agile workflows. Qualifications: * 10 years experience executing Verification & Validation (V&V) strategy for Software as a Medical Device ...

Software Design Quality Engineer

Bedford, MA ยท On-site

$102K - $163K/yr

Track and risk assess software Anomalies for pre- and post-market medical device software. * Conducts detailed root cause analyses for software quality issues and validating key design inputs like ...

Software Design Quality Engineer

Bedford, MA ยท On-site

$102K - $163K/yr

Track and risk assess software Anomalies for pre- and post-market medical device software. * Conducts detailed root cause analyses for software quality issues and validating key design inputs like ...

Software Design Assurance Eng

Bedford, MA ยท On-site

$102K - $163K/yr

Track and risk assess software Anomalies for pre- and post-market medical device software. * Conducts detailed root cause analyses for software quality issues and validating key design inputs like ...

... medical device-specific requirements including biocompatibility (ISO 10993 series), software ... testing; Computer Science/Software Engineering to IEC 62304 software lifecycle and embedded systems ...

Track and risk assess software Anomalies for pre- and post-market medical device software. * Conducts detailed root cause analyses for software quality issues and validating key design inputs like ...

Senior Software Engineer

Andover, MA ยท On-site

$129K - $183K/yr

Strong knowledge of Object-Oriented Design (OOD and Unified Modeling Language (UML) Integration of testing, static analysis, and security frameworks, a plus. Medical device software development ...

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Medical Device Software Testing information

See Boston, MA salary details

$20

$47

$75

How much do medical device software testing jobs pay per hour?

As of Aug 16, 2026, the average hourly pay for medical device software testing in Boston, MA is $47.26, according to ZipRecruiter salary data. Most workers in this role earn between $36.30 and $56.92 per hour, depending on experience, location, and employer.

What is medical device software testing?

Medical device software testing is the process of verifying and validating the software used in medical devices to ensure it is safe, reliable, and compliant with regulatory standards. This involves various testing methods, such as functional, performance, and usability testing, to identify and fix potential issues before the device is released to the market. Proper software testing helps prevent device failures that could harm patients and ensures that the device operates as intended under all expected conditions.

What are the key skills and qualifications needed to thrive as a medical device software tester?

To excel as a Medical Device Software Tester, you need a strong background in software testing methodologies, knowledge of regulatory standards like IEC 62304, and a degree in computer science or engineering. Familiarity with testing tools such as Selenium, Jira, and automated test frameworks, as well as experience with validation and verification documentation, is typically required. Attention to detail, analytical thinking, and effective communication are crucial soft skills that help testers identify issues and collaborate with cross-functional teams. These skills and qualifications are vital to ensure the safety, reliability, and compliance of medical device software in a highly regulated industry.

What are some common challenges faced by professionals in medical device software testing, and how can they be addressed?

Professionals in medical device software testing often encounter challenges such as ensuring compliance with strict regulatory standards (like FDA or ISO 13485), managing complex documentation requirements, and keeping up with frequent software updates. Addressing these challenges requires a strong focus on detail, thorough understanding of relevant regulations, and effective communication with development and quality assurance teams. Collaborating closely with cross-functional teams and maintaining up-to-date knowledge of regulatory changes are key to successfully navigating these demands.

What is the difference between Medical Device Software Testing vs Medical Device Quality Assurance?

AspectMedical Device Software TestingMedical Device Quality Assurance
CertificationsISTQB, CSTE, or similar testing certificationsISO 13485, CAPA, or quality management certifications
Work EnvironmentTesting labs, development teams, regulated environmentsQuality management systems, compliance departments
Employer & Industry UsageMedical device companies, software developersManufacturers, regulatory agencies, compliance firms
Search & Comparison IntentUnderstanding testing roles, skills, and responsibilitiesUnderstanding quality assurance processes, compliance standards

Medical Device Software Testing focuses on verifying and validating software functionalities to ensure safety and compliance. Medical Device Quality Assurance encompasses broader quality management practices, including process audits and compliance to standards. Both roles are essential in the medical device industry but serve different purposes in ensuring product safety and regulatory adherence.

Infographic showing various Medical Device Software Testing job openings in Boston, MA as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $98,309 per year, or $47.3 per hour.

Senior Software Engineer

Samsung HME America Inc

Danvers, MA โ€ข On-site

$178K - $188K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 10 days ago


Job description

Senior Software Engineer

  • Location: On-site in Danvers, MA

Who We Are

Samsung HME America (Healthcare and Medical Equipment) is Samsung’s U.S. medical imaging organization, delivering advanced diagnostic solutions across Ultrasound, Digital Radiography, and Computed Tomography. We lead nationwide sales, marketing, service, and distribution of Samsung’s imaging technologies, partnering with healthcare providers to strengthen diagnostic capabilities, streamline clinical workflows, and support better patient care. Samsung HME America also serves as the global manufacturing center for Samsung’s mobile Computed Tomography (mCT) business, leading the development of advanced CT systems used by healthcare providers worldwide.

Backed by Samsung Electronics’ global technology leadership, our teams work closely with clinicians to translate real-world challenges into innovative imaging solutions. Our culture combines a sense of urgency, customer focus, and clinical collaboration to advance the future of medical imaging. Samsung HME America, Inc. (DBA NeuroLogica, Corp.) is seeking a Senior Software Engineer.

Key duties and responsibilities, your day-to-day will include:

  • Responsible for the development and maintenance of existing and future software systems ranging from embedded control systems, image processing, to complex user interfaces for the Company’s CT and other medical device products.
  • Work closely with a team of electrical, mechanical, and software engineers, both on-site and remotely.
  • Perform all phases of software development: requirements, design, implementation, verification, and release, which include manufacturing testing and support.
  • Develop C/C++ applications, including those in embedded environments.
  • Develop C++/Qt/QML user interface applications.
  • Work closely within a development team to troubleshoot development & production environments, performance tune, and optimize embedded systems.
  • Conduct reviews and critique other engineer’s designs.
  • Work in a team environment, which encourages respectfully receiving and giving constructive criticism.
  • Review codes to ensure accuracy and act as advisor and checker for junior engineers.
  • Develop and execute unit and integration tests and collaborate with QA for system-level.
  • Develop supporting design documentation.
  • Technical leadership in writing code, code architecture, peer reviewing code, and developing requirements and system architecture is expected.
  • Provide regular status reports, written and/or verbal, to cross-functional project team members.
  • Work individually with minimal supervision and as part of team of engineers.
  • Provide technical support for manufacturing and installed base, including troubleshooting, bug-fixing, unit and system testing, and software deployment.
  • Collaborate with product and clinical teams to conduct concept, design, and prototype review.
  • Investigate new technologies and platforms.
  • Keep knowledge of all NeuroLogica products up to date.
Qualifications and Requirements: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.


Education, Skills & Experience

  • Education Requirement – Bachelor’s degree in Computer Science or Electrical and Electronics Engineering, a related field, or a foreign equivalent
  • Relevant experience – 5 years of progressively responsible post-baccalaureate experience in job offered or any software developer/engineering related job titles.
  • Applicants must have 5 years of experience in the following: (1) C/C++, Qt/QML; (2) Windows, Linux, and embedded software environments; (3) multi-threaded applications; (4) object-orientated programming concepts; (5) Communication protocols including TCP/UDP socket communication for networked systems; (6) DICOM standards and DICOM tools; (7) Medical device regulations and standards (FDA guidelines and ISO standards); and (8) medical device software development.
  • Telecommuting permitted less than 50% per week within the same geographic location as the assigned NeuroLogica office location.

Benefits

We offer a comprehensive benefit package which includes:

  • Medical (Blue Benefit Administrators): 5 PPO Plans (with up to 95% employer contribution)
  • Dental (Blue Cross Blue Shield): 2 PPO Plans (with up to 80% employer contribution)
  • Vision (Blue Cross Blue Shield): 100% company paid
  • Short/Long Term Disability, Life & AD&D (The Standard): 100% company paid
  • 401k Retirement (Fidelity): 100% company match up to 5%
  • Tax Deferred Health Care Savings Programs
  • Accident Insurance, Critical Illness, Hospital Indemnity, Pet, Legal, ID Theft
  • Generous paid time off, tuition reimbursement, and more!


Inclusion and Diversity Statement:

We are an Equal Opportunity Employer and value diversity at all levels of the organization. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other characteristic protected by applicable law. We are committed to providing reasonable accommodation to individuals with disabilities throughout the application and employment process. If you require assistance or accommodation, please contact Human Resources.