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Medical Device Software Testing Jobs in Boston, MA

Senior SQA Engineer

Natick, MA · On-site

$120K - $130K/yr

Participate in verification, testing, and documentation of medical device software per governing SOPs * Document verification procedures, verification results and traceability matrices. * Develop ...

Senior SQA Engineer

Natick, MA · On-site

$120K - $130K/yr

Participate in verification, testing, and documentation of medical device software per governing SOPs * Document verification procedures, verification results and traceability matrices. * Develop ...

Medical Device Manufacturing Industry Duration: 5 Months (possible extension) Location: Boston, MA ... testing, and validation • Define quality measures to ensure product compliance • Establish ...

... early-stage medical device startup dedicated to transforming advanced surgical visualization ... git), unit testing, and continuous integration. · Good grasp of User Experience concepts ...

... early-stage medical device startup dedicated to transforming advanced surgical visualization ... git), unit testing, and continuous integration. Good grasp of User Experience concepts ...

Principal Software Test Lead

Boston, MA · On-site

$103K - $176K/yr

... 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 ...

... early-stage medical device startup dedicated to transforming advanced surgical visualization ... git), unit testing, and continuous integration. • Good grasp of User Experience concepts ...

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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 Jun 30, 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.

Is software testing a good career?

Medical device software testing is a specialized field that involves verifying the safety and functionality of software used in medical devices. It requires knowledge of testing tools, regulatory standards, and often involves certifications like ISTQB. The role offers steady demand due to strict industry regulations and the need for quality assurance in healthcare technology.

Will AI replace medical device sales jobs?

AI is unlikely to fully replace medical device sales jobs, as these roles require relationship-building, product knowledge, and negotiation skills that are difficult for AI to replicate. Instead, AI can support sales professionals by providing data analysis, customer insights, and automating routine tasks. Success in this field often depends on interpersonal skills, technical understanding, and certifications, which remain essential despite technological advancements.

What is the highest paying tech in the medical field?

In the medical device software testing field, roles such as senior software engineers, quality assurance managers, and regulatory compliance specialists tend to have the highest salaries. These positions often require advanced technical skills, certifications, and experience with medical standards like ISO 13485 or IEC 62304.

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 is a QA in medical devices?

A QA (Quality Assurance) in medical devices involves systematically reviewing and testing software to ensure it meets safety, performance, and regulatory standards. QA professionals in this field often use validation, verification, and risk management processes, and may require knowledge of standards like ISO 13485 and FDA regulations.

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, and why are they important?

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 are popular job titles related to Medical Device Software Testing jobs in Boston, MA? For Medical Device Software Testing jobs in Boston, MA, the most frequently searched job titles are:
What job categories do people searching Medical Device Software Testing jobs in Boston, MA look for? The top searched job categories for Medical Device Software Testing jobs in Boston, MA are:
Infographic showing various Medical Device Software Testing job openings in Boston, MA as of June 2026, with employment types broken down into 33% Full Time, 33% Temporary, and 34% Contract. Highlights an 100% In-person job distribution, with an average salary of $98,309 per year, or $47.3 per hour.

Senior SQA Engineer

Intuvie

Natick, MA • On-site

$120K - $130K/yr

Full-time

Posted 19 days ago


Key responsibilities

  • Participate in verification, testing, and documentation of medical device software per governing SOPs.

  • Create, execute, and maintain test scripts for use within projects and regression testing.

  • Document verification procedures, verification results, traceability matrices, and testing methodologies, along with defect tracking and reporting.


Job description

Position Title: Senior SQA Engineer Department: Product Development


Reports To: Principal SQA Engineer/Tech Lead FLSA: exempt

GENERAL SUMMARY

Senior SQA Engineer is a senior-level position that involves the testing and verification of complex software solutions to ensure they meet quality standards. This role identifies software defects and contributes to the delivery of high-quality products that meet the needs of the intended use of our products as well as the quality and regulatory expectations for medical device development and production.


ESSENTIAL JOB FUNCTIONS

  • Participate in verification, testing, and documentation of medical device software per governing SOPs
  • Document verification procedures, verification results and traceability matrices.
  • Develop solid understanding of the medical device software products
  • Document testing methodologies, along with defect tracking and reporting.
  • Create, execute, and maintain test scripts for use within projects and regression testing.
  • Set up and maintain testing environments for different testing needs
  • Work closely with the software engineering team in all phases of the development cycle.
  • May work on automating verification procedures to achieve test automation of the medical device software products
  • Mentor more junior SQA engineers and conduct technical training for the SQA engineering team.
OTHER DUTIES AND RESPONSIBILITIES
  • Additional responsibilities may or may not be assigned to the employee; role assignment will be reviewed on a case-by-case basis determinant upon individual strengths, experience, knowledge, and expertise.


PREPARATION, KNOWLEDGE, SKILLS & ABILITIES
  • 5-10 years of experience with a bachelor’s degree, 3-7 years of experience with a master’s degree, or 1-5 years of experience with a PhD degree in mathematics, computer science, engineering, or related field from a 4-year college or university.
  • 3-5 years’ experience in software testing of medical device software.
  • Strong understanding of test automation is a plus.
  • Good testing knowledge and experience of software applications.
  • Good knowledge of QA process development and testing experience with software that has a hardware component is a plus.
  • A strong sense of software quality and attention to details.
  • Excellent written and verbal communication skills.
  • Strong analytical problem solving skills.
  • Ability to mentor staff
  • Ability to work successfully in various sizes of teams or independently to meet project deadlines.