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Medical Device Software Testing Jobs in Boston, MA

Nova Biomedical

Senior Software QA Engineer

Norwood, MA · On-site

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

... medical device regulations. * Maintain accurate and traceable software test records in accordance ... Apply risk-based testing strategies to prioritize high-impact product functionality and patient or ...

Nova Biomedical

Senior Software QA Engineer

Norwood, MA · On-site

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

... medical device regulations. * Maintain accurate and traceable software test records in accordance ... Apply risk-based testing strategies to prioritize high-impact product functionality and patient or ...

Freseniusglobal

Sr Engineer (Control Systems)

North Andover, MA · Hybrid

$179K - $185K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Plans, documents, executes and reports on software verification testing of large medical device software applications with minimal supervision Performs configuration management activities for ...

Inherent Technologies

Project Engineer

Danvers, MA · On-site

Minimum of 1 year experience in the medical device industry as well as Medical Device Software systems and cardiovascular devices highly preferred (Class III medical device experience strongly ...

Fresenius Kabi

Sr Engineer (Control Systems)

Andover, MA · On-site

$169K - $175K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Plans, documents, executes and reports on software verification testing of large medical device software applications with minimal supervision Performs configuration management activities for ...

Johnson Controls

Software Engineer, Device

Boston, MA

$70K - $110K/yr

As a Software Engineer, Device, you'll develop robust and expandable solutions for our on-device ... experience building, testing, and shipping high quality production code * Experience with ...

Johnson Controls

Software Engineer, Device

Burlington, MA · On-site

$70K - $110K/yr

As a Software Engineer, Device, you'll develop robust and expandable solutions for our on-device ... experience building, testing, and shipping high quality production code * Experience with ...

Johnson Controls

Software Engineer, Device

Burlington, MA · On-site

$70K - $110K/yr

As a Software Engineer, Device, you'll develop robust and expandable solutions for our on-device ... testing, and shipping high quality production code * Experience with Industrial Machines and ...

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All JobsMedical Device Software Testing JobsMedical Device Software Testing Jobs in Boston, MA

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 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 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.
Medical Device Software Testing jobs near you
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 Designs Assurance Quality Engineer

Access Vascular

Billerica, MA • On-site

$135K - $160K/yr

Full-time

Re-posted 4 days ago

Job description

Job Description

Manage the Design Control and product design and change Risk Management processes for sterile catheter-, software-, electromechanical-based medical device product families. Provide Quality Engineering support for Product Development Projects throughout all phases of Design Controls (Concept to Launch) and Design Risk Management.

This is a key contributor position working closely with R&D, Operations, Commercial, Regulatory and Operations Quality to ensure compliance with AVI's QMS and FDA QMSR requirements, with particular focus on Design Controls and Risk Management.

Duties &

Responsibilities

· Responsible for overall Design Quality process to ensure that company design control projects comply with internal design control and risk management procedures in accordance with FDA, ISO and other applicable requirements

· Lead cross functional teams to implement and periodically review hazard analyses, risk evaluation, assessment and other risk management processes

· Provide guidance to project team members to ensure that design control requirements are being met in an effective manner in order to achieve quality by design

· Support development, implementation and maintenance of Design Verification & Validation methodologies and best practices to impact product quality and launch timeliness

· Collaborate with Operations and Operations Quality to ensure effective and successful design transfer to manufacturing

· Drive quality focused design and development of device software by defining the requirements, design, verification and validation plan and strategies while maintaining traceability and compliance to IEC 62304 and FDA guidance documents related to medical device software

· Participate in product cybersecurity activities including product security planning, threat analysis, cybersecurity risk assessments, periodic monitoring and reporting

· Act as a subject matter expert for Quality Engineering practices, such as statistical analysis, failure investigations, hazard identification and risk analysis, and quality data trending and analysis

· Assist in Post-Market Surveillance (PMS) initiatives, including failure investigation, record review, and data trending

Qualifications

· BS in Mechanical, Electrical, or Biomedical Engineering or other scientific or related discipline

· 5-8 years of design assurance experience in medical device design and manufacturing environment

· Proven track record of completing new product introduction transfers to Operations

· Working knowledge of Medical Device Regulation FDA 21 CFR 820 and ISO 14971, 13485, ISO 10993, IEC 60601 and IEC 62304 series of standards, other applicable regulations and industry standards pertaining to the design of medical devices

· Experience with preparing and reviewing design documentation in support of regulatory submissions

· Working knowledge of data analysis methods, including basic statistics, preferably using Minitab or other similar data analysis software

· Working knowledge with various quality tools such as Failure Mode and Effects Analysis (FMEA) and Use Related Risk Analysis (URRA), Statistical Process Control (SPC), Root Cause Analysis (RCA), Measurement Systems Analysis (MSA) & Gage Repeatability and Reproducibility (Gage R&R)

· Experience with manufacturing complex medical devices, including process validation and equipment qualification requirements (IQ/OQ/PQ).

· Experience managing third-party development and test organizations.

· Ability to communicate ideas and information clearly, effectively, and concisely

· Possess the following key traits: teamwork, flexibility and adaptability to change, critical reasoning and excellent data presentation skills, excellent written and verbal communication and skills

The ideal candidate must have a foundation in being a self-starter with strong organization skills.

Compensation Commensurate With Experience
$135,000—$160,000 USD
About Access Vascular

Access Vascular was founded in 2015 to address the most common and costly complications of intravenous therapy: infection, thrombosis and phlebitis. The company is developing a suite of venous access devices made from patented biomaterials which are highly biocompatible and have demonstrated 6X fewer complications. .

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