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Medical Device Software Testing Jobs in Boston, MA

Philips

Software Design Quality Engineer

Bedford, MA · 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 ...

Philips

Software Design Quality Engineer

Bedford, MA · 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 ...

SharkNinja

Compliance Engineer

Needham, MA

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

Philips

Software Design Assurance Eng

Bedford, MA · 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 ...

Jj

Medical Device Assembler (1st/2nd Shift)

Danvers, MA · On-site

$45K - $73K/yr

The Cleanroom Medical Device Assembler will be responsible for assembling, inspecting and testing high quality medical devices while working within a controlled manufacturing system. Principle Duties ...

Philips

Software Design Assurance Eng

Bedford, MA · 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 ...

Trelleborg

Software Validation Engineer

Northborough, MA · On-site

$95K - $105K/yr

Strong understanding of regulatory requirements and software testing methodologies for the pharmaceutical and medical device industry * Experience with supplier audits or vendor qualification.

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Medical Device Software Testing information

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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:
Medical Device Software Testing jobs near you
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.
Software Design Quality Engineer

Software Design Quality Engineer

Philips

Bedford, MA • On-site

$102K - $163K/yr

Full-time

Retirement, PTO

Posted 3 days ago

Philips rating

8.2

Company rating: 8.2 out of 10

Based on 79 frontline employees who took The Breakroom Quiz

36th of 141 rated electronics manufacturers

Job description

Job Title
Software Design Quality Engineer
Job Description
The Software Design Quality Engineer is responsible for developing, maintaining, and managing comprehensive software quality documentation, ensuring their accuracy and regulatory compliance throughout the software lifecycle.
Your role:
  • Leads the assessment of software designs by reviewing test and performance data to uphold quality, safety, and regulatory standards, and address any engineering deficiencies.
  • Lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation including- Software design/verification, Risk management, Systems validation, Traceability and Cyber security risk management.
  • 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 usability, reliability, and performance.
  • Assess products and systems to identify defects, abnormalities and design flaws by authoring and executing software test protocols and generating test reports.
  • Implements software quality plans and risk management activities, utilizes post-market analytics to monitor software performance, and initiates corrective actions as needed.
  • Ensure compliance across the product software lifecycle by overseeing regulatory planning and execution for new products and changes as well as managing filings and approvals by overseeing preparation and submission of documentation for global registrations to enable timely market access.
  • Drive regulatory excellence and continuous improvement by developing plans, assessing risks, implementing actions, and optimizing regulatory processes for efficiency while maintaining high compliance standards.

You're the right fit if:
  • You have a minimum of 5+ years' experience in FDA regulated, IEC 62304 medical device software environments, with a focus on Software Design Assurance/Control, detailed knowledge of Risk Management (ISO 14971), SDLC and strong Understanding of all aspects of the QMS related to Software Design Controls.
  • You have proven experience in Root Cause Analysis, Software V&V, identifying/ supporting processes and design quality tools for use in tracking/preventing software defects, design traceability, Design for Quality (DfQ), Agile, and SAFe.
  • Strong experience with complex medical systems containing software, hardware and disposables.
  • You're able to share knowledge, insights regarding software quality standards, and regulatory requirements.
  • You have excellent written and verbal communication skills, with the ability to communicate and present to all levels of management.
  • Ability to interpret software design and code (C/C++/C# or any other object-oriented language) to verify implementation of requirements.
  • You have a minimum of a Bachelor's Degree (Required), in Quality, Computer Science/Engineering or similar disciplines. ISTQB certification desired.
  • You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

How we work together:
We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time (5 days per week) presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is an ON-SITE role.
About Philips:
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality. healthcare that we all deserve. Do the work of your life to help improve the lives of others.
  • Learn more about our business.
  • Discover our rich and exciting history.
  • Learn more about our purpose.
  • Learn more about our culture.

Philips Transparency Details:
  • The pay range for this position in Bedford, MA is $102,480 to $163,968.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.
At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.
In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.
Additional Information:
  • US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
  • Company relocation benefits WILL NOT be provided for this position. For this position, you must reside in or within commuting distance to Bedford, MA.
  • May require travel up to 10%.

#LI-PH1
This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

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