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Medical Device Software Testing Jobs in Massachusetts

Abbott

Senior Software Verification Engineer

Burlington, MA · On-site

$78K - $156K/yr

The Opportunity The Senior Software Verification Engineer will plan, develop, and execute software ... Hybrid Testing: Balance manual exploration of physical medical device hardware with the expansion ...

New

Nova Biomedical

Software Engineer Manager

Norwood, MA · On-site

Ensure software development activities comply with ISO 13485 requirements and applicable medical device quality system procedures. * Guide the design, development, testing, integration, and ...

Collaborative LLC

Be Seen First

Medical Device Assembler

Westford, MA · On-site

$21.51/hr

THE POSITION: has a Medical Device Assembler, you will work as part of a manufacturing cell assembling, inspecting, testing, and packaging cardiovascular medical devices and related components. ABOUT:

Jj

Staff Quality Engineer Product Quality

Boston, MA · On-site

$78K - $101K/yr

Support the design, development and testing of Medical Device Software, including Software as a Medical Device (SaMD) products. * Provide leadership, guidance and expertise on the software ...

Jj

Staff Quality Engineer Product Quality

Raynham, MA · On-site

$74K - $96K/yr

Support the design, development and testing of Medical Device Software, including Software as a Medical Device (SaMD) products. * Provide leadership, guidance and expertise on the software ...

Jobtailor

Software Engineer, Device

Burlington, MA · On-site

$90 - $120/hr

* Develop robust and expandable solutions for on-device software * Work on motion planning and ... testing, and shipping high quality production code * Experience with Industrial Machines and ...

New

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Medical Device Software Testing information

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.

What cities in Massachusetts are hiring for Medical Device Software Testing jobs?

Cities in Massachusetts with the most Medical Device Software Testing job openings:

Medical Device Software Testing jobs near you
Infographic showing various Medical Device Software Testing job openings in Massachusetts as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 12% Part Time, and 6% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution.

Embedded Software Test Engineer (Medical Devices)

TekCommands Inc

Burlington, MA • On-site

Contractor

Re-posted 13 days ago

Job description

Job Description:
We are seeking an experienced Embedded Software Test Engineer to join our Medical Devices team. In this role, you will be responsible for designing, implementing, and executing tests for embedded software systems in medical devices. You will work closely with cross-functional teams to ensure software quality, regulatory compliance, and patient safety through rigorous verification and validation activities.

Key Responsibilities:
Create and maintain test documentation in compliance with FDA, IEC 62304, ISO 13485, and other relevant standards
Participate in risk management activities to identify software-related hazards and mitigations
Define test coverage requirements based on software requirements and risk analysis
Design detailed test cases for functional, integration, regression, and system-level testing
Create test specifications that ensure traceability to software requirements
Develop automated test scripts for embedded systems using appropriate test frameworks
Design test environments and fixtures that simulate real-world usage conditions

Mandatory skills
Bachelor's degree in Computer Science, Electrical Engineering, Biomedical Engineering, or related field
6+ years of experience in embedded software testing, preferably in medical devices
Strong understanding of software development life cycle and V-model
Knowledge of regulatory requirements for medical device software (FDA, IEC 62304, ISO 13485)
Familiarity with embedded software debugging tools and techniques"
Optional skills
Strong analytical and problem-solving abilities
Excellent documentation and technical writing skills
Ability to work effectively in cross-functional teams
Attention to detail and commitment to quality
Strong communication skills with both technical and non-technical stakeholders
Self-motivated with the ability to work independently