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Medical Device Software Testing Jobs (NOW HIRING)

Intuvie

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 ...

Intuvie

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 ...

Abbott

Software Quality Engineer

Alameda, CA · On-site

$80 - $85/hr

... Testing experience. * Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11. Has ... Medical Device experience strongly preferred. * Cybersecurity, medical web and mobile applications ...

Zimmer, Inc.

Software Quality Manager

Austin, TX

Proficiency in Verification & Validation (V&V), Design Controls, Software Testing (SDLC), and Hardware Testing, Solid understanding of Medical Device in Design Control * Experience in drafting formal ...

Abbott

Software Compliance Engineer

Milpitas, CA

Must have 1 - 3 years project experience in software testing practices, methodologies including ... Medical Device experience strongly preferred. * Cybersecurity, medical mobile applications or cloud ...

Abbott

Software Compliance Engineer

Alameda, CA

Must have 1 - 3 years project experience in software testing practices, methodologies including ... Medical Device experience strongly preferred. * Cybersecurity, medical mobile applications or cloud ...

Abbott

Software Compliance Engineer

Milpitas, CA

Must have 1 - 3 years project experience in software testing practices, methodologies including ... Medical Device experience strongly preferred. * Cybersecurity, medical mobile applications or cloud ...

Abbott

Software Compliance Engineer

Alameda, CA

Must have 1 - 3 years project experience in software testing practices, methodologies including ... Medical Device experience strongly preferred. * Cybersecurity, medical mobile applications or cloud ...

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Medical Device Software Testing information

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$19

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

As of Jul 21, 2026, the average hourly pay for medical device software testing in the United States is $43.50, according to ZipRecruiter salary data. Most workers in this role earn between $33.41 and $52.40 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, 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.
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Medical Device Software Testing jobs near you
Infographic showing various Medical Device Software Testing job openings in the United States as of July 2026, with employment types broken down into 77% Full Time, 14% Part Time, and 9% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $90,490 per year, or $43.5 per hour.
Senior Software Quality Engineer - Global Device Software Steward Support

Senior Software Quality Engineer - Global Device Software Steward Support

Boston Scientific

Arden Hills, MN • On-site, Remote

Full-time

This job post has expired 1 day ago. Applications are no longer accepted.

Boston Scientific rating

8.5

Company rating: 8.5 out of 10

Based on 119 frontline employees who took The Breakroom Quiz

33rd of 528 rated manufacturers

Job description


Recruiter: Spencer Gregory Hale

Senior Software Quality Engineer – Global Device Software Steward Support 

Travel amount: Up to 10% 

Remote Eligible:  Hybrid 

Onsite Location(s): Hybrid in MN 

About the role: 

This Device Software Sub-Process Steward Support role teams with the Device Software Sub-Process Steward to help with leadership and oversight to the Device Software sub-process. The Device Software sub-process controls device software considered a finished medical device or used as a component, part, or accessory of a medical device developed, subcontracted, modified, or purchased. Quality System Stewards use the Best4 (Culture, Agility, Performance, Compliance) Strategy to enable our Quality Policy.  Global Quality System Device Software sub-process maintain oversight of all processes in their assigned Sub-Process. Sub-Process Stewards work together to maintain their assigned Process(es) and ensure all responsibilities are fulfilled. 

Your responsibilities will include: 

  • Best Culture:  

  • Sustain Device Software Community of Practice (CoP).  

  • Provide subject matter expertise for the organization and collaborate with site/divisional experts.  

  • Write applicable annual quality goals and objectives with input from sites, divisions, regions, and leadership to align with Best4 and organizational strategies. Support and update goals and objectives throughout the year. 

  • Best Agility:  

  • Monitor Device Software Sub-Process and implement process improvements based on performance feedback.  

  • Drive value improvement projects (VIP) to support organizational goals.  

  • Support acquisition integration as needed.  

  • Increase Quality System simplicity, efficiency and predictability with standardization and lean practices.  

  • Maintain and enhances internal and external relationships in support of the Global Quality System Process/Sub-Process.  

  • Best Performance  

  • Monitor and mitigate Quality System Process compliance risk where appropriate.  

  • Lead or oversee quality projects of major magnitude and scope.  Provide input to overall quality project portfolio and project priorities.  

  • Determine if changes are reportable to notified bodies.  

  • Initiative corporate preventive CAPAs and own or participate in corporate preventive CAPA teams.  

  • Create, implement, and sustain measures and metrics to monitor Device Software Sub-Process health.  

  • Provide metrics, data and analysis for management review. 

  • Best Compliance:  

  • Establish and maintain Global Quality System Device Software Sub-Process to ensure compliance with applicable quality and regulatory requirements. 

  • Review of new Laws Regulations Standards and Guidance’s (LRGS) and the implementation of new requirements into the BSC Quality System.  

  • Communicate new and updated requirements.  

  • Provide subject matter expertise and support for corporate and site internal and external audits.  -  

  • Review quarterly data per Quality System Process Compliance Assessment.  

  • Support the audit non-conformance response strategies.  

  • Identify Global Quality System Device Software Sub-Process training requirements.  

  • Support corporate NCEP & CAPA Processes.   

  • Assess reportability of substantial Quality System Changes.  

  • Ensuring quality records are created, maintained and dispositioned.  

Required Qualifications: 

  • Bachelor’s level degree in Science/Engineering/Computer Science/Software Engineering discipline and/or Minimum of 4 years of related experience in the Medical Device regulated industry.  

  • Working knowledge of regional and international quality system requirements including 21 CFR 820, ISO 13485, IEC 62304; ISO 14971; FDA Guidance – General Principles of Software Validation and Computer Software Assurance for Production and Quality System Software. 

  • Must have good understanding of quality system requirements and how each quality system element connects. 

  • Comfortable speaking and presenting to leadership  

  • Strong written and verbal communication skills in English 

  • Experience managing projects and project deliverables to completion  

  • Comfortable working independently and as part of a cross-functional team  

  • Ability to manage multiple priorities  

  • Proficient in Microsoft Office 

  • Works willingly and effectively with others in and across the organization to accomplish team goals with excellent interpersonal and networking skills. 

  • Values people’s opinions and encourages knowledge sharing. High level of energy, drive and enthusiasm 

  • Knowledge of Software Engineering Principles and Software Development Life Cycle (SDLC)  

  • Ability to work independently and collaborate with cross-functional teams to complete projects 

  • Strong critical thinking and analytical skills: process and results-oriented 

  • Detail oriented with strong organizational skills; ability to multi-task and prioritize competing responsibilities effectively 

Preferred Qualifications: 

  • Device Software Engineering Experience, including: 

  • Device Software Development 

  • Device Software Testing / Verification 

  • Risk Management 

  • Cybersecurity 

  • Artificial Intelligence / Machine Learning  

  • Agile Practices 

  • Experience in supporting and enhancing the QMS processes including: 

  • Device Software Development 

  • Design Controls 

  • Risk Management 

  • Post Market and Premarket Cybersecurity 

  • Experience working with Medical Device Software Advocacy, Standards and Professional Organizations (i.e. AAMI; MDIC; IEC; FDA; AdvaMed; NIST; IMDRF) 

  • Formal Project Management Experience 

  • CAPA, Vendor Controls, Complaint Handling and Internal/External Audits Experience 

  • Software Development Tools Experience (i.e. Jira; Cockpit; Github; Codenvy; Bitbucket)  

Requisition ID: 630662 

Minimum Salary: $ 85000 

Maximum Salary: $ 161500 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.  The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.  

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