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 ...
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 ...
Principal Software Quality Assurance Engineer (Remote - United States)
San Antonio, TX · On-site
$121K - $163K/yr
... medical device related standards, such as ISO 13485, ISO 14971, IEC 62304, IEC 81001-5 series amongst others. * Experience developing and testing software systems, SaMD, SiMD, and/or embedded ...
Principal Software Quality Assurance Engineer (Remote - United States)
San Antonio, TX · On-site
$121K - $163K/yr
... medical device related standards, such as ISO 13485, ISO 14971, IEC 62304, IEC 81001-5 series amongst others. * Experience developing and testing software systems, SaMD, SiMD, and/or embedded ...
Principal Software Quality Assurance Engineer (Remote - United States)
San Antonio, TX · On-site +1
$121K - $163K/yr
... medical device related standards, such as ISO 13485, ISO 14971, IEC 62304, IEC 81001-5 series amongst others. * Experience developing and testing software systems, SaMD, SiMD, and/or embedded ...
Principal Software Quality Assurance Engineer (Remote - United States)
San Antonio, TX · On-site +1
$121K - $163K/yr
... medical device related standards, such as ISO 13485, ISO 14971, IEC 62304, IEC 81001-5 series amongst others. * Experience developing and testing software systems, SaMD, SiMD, and/or embedded ...
We are testing titling to see which attracts the most qualified candidates. Please only apply to ... regulated medical device software. These systems will support the full software lifecycle, from ...
We are testing titling to see which attracts the most qualified candidates. Please only apply to ... regulated medical device software. These systems will support the full software lifecycle, from ...
Title : Medical Device Tester II Location : Plano, TX Duration : 6 Months 100% Onsite Position ... Support system-level testing, including firmware/software integration * Ensure compliance with ...
Title : Medical Device Tester II Location : Plano, TX Duration : 6 Months 100% Onsite Position ... Support system-level testing, including firmware/software integration * Ensure compliance with ...
Familiar with automated software testing, preferably in the context of medical devices software ... Familiarity with medical device requirements such as Quality System Regulation (21 CFR part 820 ...
Quick apply
Familiar with automated software testing, preferably in the context of medical devices software ... Familiarity with medical device requirements such as Quality System Regulation (21 CFR part 820 ...
Software Validation Engineer 2
Austin, TX · On-site
$70K - $105K/yr
Review and approve software validation documentation for both medical and non-medical device ... validation and testing activities. * Mechanical, Chemical or Biomedical Engineering degree ...
Software Validation Engineer 2
Austin, TX · On-site
$70K - $105K/yr
Review and approve software validation documentation for both medical and non-medical device ... validation and testing activities. * Mechanical, Chemical or Biomedical Engineering degree ...
Medical Device Recovery Agent
Lubbock, TX · On-site
$385/wk
Device Recovery Manager Location : /South Carolina/ North Carolina/ Georgia /Virginia (On the Road) Blackstone Medical Services is dedicated to providing exceptional at-home sleep testing for sleep ...
Medical Device Recovery Agent
Lubbock, TX · On-site
$385/wk
Device Recovery Manager Location : /South Carolina/ North Carolina/ Georgia /Virginia (On the Road) Blackstone Medical Services is dedicated to providing exceptional at-home sleep testing for sleep ...
... medical device software. Key Responsibilities AI Tooling and Integration • Evaluate, implement ... and testing. • Identify and pilot AI use cases in V&V processes, including automated test ...
Quick apply
... medical device software. Key Responsibilities AI Tooling and Integration • Evaluate, implement ... and testing. • Identify and pilot AI use cases in V&V processes, including automated test ...
Medical Device Assembler
Allen, TX · On-site
$16.75 - $20.50/hr
We are seeking a Medical Device Assembler I to join our production team. In role, you will work in ... software is a plus Strong attention to detail and manual dexterity Ability to sit or stand for ...
Medical Device Assembler
Allen, TX · On-site
$16.75 - $20.50/hr
We are seeking a Medical Device Assembler I to join our production team. In role, you will work in ... software is a plus Strong attention to detail and manual dexterity Ability to sit or stand for ...
Medical Device Assembler
Richardson, TX · On-site
$16.25 - $20/hr
We are seeking a Medical Device Assembler I to join our production team. In role, you will work in ... software is a plus Strong attention to detail and manual dexterity Ability to sit or stand for ...
Medical Device Assembler
Richardson, TX · On-site
$16.25 - $20/hr
We are seeking a Medical Device Assembler I to join our production team. In role, you will work in ... software is a plus Strong attention to detail and manual dexterity Ability to sit or stand for ...
Medical Device Assembler
Garland, TX · On-site
$15.75 - $19.50/hr
We are seeking a Medical Device Assembler I to join our production team. In role, you will work in ... software is a plus Strong attention to detail and manual dexterity Ability to sit or stand for ...
Medical Device Assembler
Garland, TX · On-site
$15.75 - $19.50/hr
We are seeking a Medical Device Assembler I to join our production team. In role, you will work in ... software is a plus Strong attention to detail and manual dexterity Ability to sit or stand for ...
Medical Device Assembler
Dallas, TX · On-site
$17.50 - $21.50/hr
We are seeking a Medical Device Assembler I to join our production team. In role, you will work in ... software is a plus Strong attention to detail and manual dexterity Ability to sit or stand for ...
Medical Device Assembler
Dallas, TX · On-site
$17.50 - $21.50/hr
We are seeking a Medical Device Assembler I to join our production team. In role, you will work in ... software is a plus Strong attention to detail and manual dexterity Ability to sit or stand for ...
Medical Device Assembler
Frisco, TX · On-site
$17 - $20.75/hr
We are seeking a Medical Device Assembler I to join our production team. In role, you will work in ... software is a plus Strong attention to detail and manual dexterity Ability to sit or stand for ...
Medical Device Assembler
Frisco, TX · On-site
$17 - $20.75/hr
We are seeking a Medical Device Assembler I to join our production team. In role, you will work in ... software is a plus Strong attention to detail and manual dexterity Ability to sit or stand for ...
Medical Device Assembler
Plano, TX · On-site
$17.25 - $21.25/hr
We are seeking a Medical Device Assembler I to join our production team. In role, you will work in ... software is a plus Strong attention to detail and manual dexterity Ability to sit or stand for ...
Medical Device Assembler
Plano, TX · On-site
$17.25 - $21.25/hr
We are seeking a Medical Device Assembler I to join our production team. In role, you will work in ... software is a plus Strong attention to detail and manual dexterity Ability to sit or stand for ...
Medical Device Assembler
Frisco, TX · On-site
$16.50 - $20.25/hr
We are seeking a Medical Device Assembler I to join our production team. In role, you will work in ... software is a plus Strong attention to detail and manual dexterity Ability to sit or stand for ...
Medical Device Assembler
Frisco, TX · On-site
$16.50 - $20.25/hr
We are seeking a Medical Device Assembler I to join our production team. In role, you will work in ... software is a plus Strong attention to detail and manual dexterity Ability to sit or stand for ...
Medical Device Assembler
Richardson, TX · On-site
$16.25 - $19.75/hr
We are seeking a Medical Device Assembler I to join our production team. In role, you will work in ... software is a plus Strong attention to detail and manual dexterity Ability to sit or stand for ...
Medical Device Assembler
Richardson, TX · On-site
$16.25 - $19.75/hr
We are seeking a Medical Device Assembler I to join our production team. In role, you will work in ... software is a plus Strong attention to detail and manual dexterity Ability to sit or stand for ...
... medical device software. Key Responsibilities AI Tooling and Integration • Evaluate, implement ... and testing. • Identify and pilot AI use cases in V&V processes, including automated test ...
Quick apply
... medical device software. Key Responsibilities AI Tooling and Integration • Evaluate, implement ... and testing. • Identify and pilot AI use cases in V&V processes, including automated test ...
Medical Device Assembler
$16.75 - $20.50/hr
We are seeking a Medical Device Assembler I to join our production team. In role, you will work in ... software is a plus Strong attention to detail and manual dexterity Ability to sit or stand for ...
Medical Device Assembler
$16.75 - $20.50/hr
We are seeking a Medical Device Assembler I to join our production team. In role, you will work in ... software is a plus Strong attention to detail and manual dexterity Ability to sit or stand for ...
Medical Device Assembler
Plano, TX · On-site
$16.75 - $20.50/hr
We are seeking a Medical Device Assembler I to join our production team. In role, you will work in ... software is a plus Strong attention to detail and manual dexterity Ability to sit or stand for ...
Medical Device Assembler
Plano, TX · On-site
$16.75 - $20.50/hr
We are seeking a Medical Device Assembler I to join our production team. In role, you will work in ... software is a plus Strong attention to detail and manual dexterity Ability to sit or stand for ...
Medical Device Software Testing information
See Texas salary details
$17.92 - $22.21
6% of jobs
$22.21 - $26.51
8% of jobs
$30.70 is the 25th percentile. Wages below this are outliers.
$26.51 - $30.80
11% of jobs
$30.80 - $35.10
18% of jobs
The median wage is $37.09 / hr.
$35.10 - $39.40
15% of jobs
$39.40 - $43.69
5% of jobs
$43.69 - $47.99
11% of jobs
$48.44 is the 75th percentile. Wages above this are outliers.
$47.99 - $52.28
13% of jobs
$52.28 - $56.58
8% of jobs
$56.58 - $60.88
4% of jobs
$60.88 - $65.17
1% of jobs
$17
$40
$65
How much do medical device software testing jobs pay per hour?
What is the difference between Medical Device Software Testing vs Medical Device Quality Assurance?
| Aspect | Medical Device Software Testing | Medical Device Quality Assurance |
|---|---|---|
| Certifications | ISTQB, CSTE, or similar testing certifications | ISO 13485, CAPA, or quality management certifications |
| Work Environment | Testing labs, development teams, regulated environments | Quality management systems, compliance departments |
| Employer & Industry Usage | Medical device companies, software developers | Manufacturers, regulatory agencies, compliance firms |
| Search & Comparison Intent | Understanding testing roles, skills, and responsibilities | Understanding 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?
What are the key skills and qualifications needed to thrive as a Medical Device Software Tester, and why are they important?
What are some common challenges faced by professionals in medical device software testing, and how can they be addressed?
- Manager Biotech Graduate
- Internship Product Manager Medical Device
- Internship Orthopedic Device Sales
- Surgical Instrument Sales
- Commission International Medical Device Sales
- Medical Device Sales Manager
- Business Intelligence Germany
- Strategic Pharmaceutical Solutions
- Overnight Complaint Handling Medical Device
- Manager Finance Pharmaceutical

Other
Posted 2 days ago
Job description
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.
Manage software testing teams for manual & automated testing and analysis to identify defects, verify software requirements and prepare documents based on the company QMS(Quality Management System) and regulatory environment, and provide leadership to Software Test Engineers.
Essential Responsiblities:
- Manage SW verification and Software release strategy based on the USA FDA, European and Asia Pacific in a regulatory environment
- Provide leadership and supervision to testing teams on multiple projects, mentor, and manage a team of SW Test engineers onshore & offshore, overseeing daily operations, workload prioritization
- Plan schedules for formal cycle testing
- Guide test teams to prepare & execute test cases (manual / automated), prepare test plans and test protocols.
- Submit defects reports using defect tracking application and follow through on its resolution
- Prepare weekly test metrics and present report to SW director on a regular basis
- Participate in Defect Review Board and work with Software Quality Engineer to follow up on features & defects Ability to travel is required
- Verify all software systems comply US FDA's 21 CFR Part 820 (QMSR) and IEC 62304 (Medical Device Software Lifecycle Processes)
- Collaborate with Software Development Team & Software Quality Assurance teams to follow the company Quality procedures
- Prepare Delivery of Software Master Test Plans, Test Protocols per formal testing cycles
- Ensure Testing cycles are executed on timely manners with sufficient resources
- Provide Support post-market for installation
- Continuous execution of Dry Run testing
- Support internal & external audit when required
- Support Manual Testing when required Verify traceability matrices linking user needs requirements, System Design specifications, and test cases
- Liaison between Software Development team, Software Quality Assurance team
- Collaborate with DevOps and Software Development teams to integrate manual and automated test suites into CI/CD pipelines while ensuring compliance with FDA and IEC 62304 requirements
- Familiarity with Test management tool such as Jira, Jama or equivalent and automation frame works
- Deep understanding of FDA, ISO 13485 (Quality Management Systems), ISO 14971 (Risk Management), IEC 62304 (Software Lifecycle), Cybersecurity (ANSI/AAMI SW96, IEC 81001-5-1, NIST), and EU MDR, Software in and Software as a Medical Device (SiMD/SaMD)
- Minimum of Bachelor's degree in Biomedical or Mechatronics or Computer Engineering, or a related field
- 5-8+ years of software testing experience, with at least 4+ years in a Lead or Managerial role within the medical device or a regulated industry.
- Has lead group of test engineers on multiple projects simultaneously
- 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 requirements
- Solid understanding Risk Assessment & Mitigation process
- Proficiency in written and spoken English
15-20%
EOE/M/F/Vet/Disability
Employment Type: OTHER