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Medical Device Validation Engineer Jobs in Arizona

Innovative Health

Sr. R&D Engineer

Scottsdale, AZ · On-site

$105K - $144K/yr

Essential Duties and Responsibilities: · Lead development of advanced medical device reprocessing ... and validation planning. · Lead or contribute to disassembly, component replacement, and ...

Innovative Health LLC

Sr. R&D Engineer

Scottsdale, AZ · On-site

$101K - $139K/yr

Essential Duties and Responsibilities: • Lead development of advanced medical device reprocessing ... and validation planning. • Lead or contribute to disassembly, component replacement, and ...

Innovative Health LLC

Sr. R&D Engineer

Scottsdale, AZ · On-site

$101K - $139K/yr

Essential Duties and Responsibilities: · Lead development of advanced medical device reprocessing ... and validation planning. · Lead or contribute to disassembly, component replacement, and ...

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Medical Device Validation Engineer information

What are some common challenges faced by medical device validation engineers during the validation process?

Medical Device Validation Engineers often encounter challenges such as ensuring compliance with evolving regulatory standards, managing tight project timelines, and coordinating cross-functional teams. Additionally, they must address unexpected technical issues that arise during testing and validation, and meticulously document results to meet quality and audit requirements. Effective communication and adaptability are crucial for successfully navigating these challenges and delivering safe, effective medical devices.

What does a medical device validation engineer do?

A Medical Device Validation Engineer is responsible for ensuring that medical devices meet regulatory and quality standards before they reach the market. They design and execute tests to validate that products perform as intended, documenting procedures and results to comply with industry regulations such as FDA and ISO guidelines. Their work involves collaborating with design, manufacturing, and quality assurance teams to identify risks and verify that devices are safe and effective for use. This role is crucial for patient safety and for a company's ability to market medical products globally.

Are medical device validation engineers in demand?

Medical device validation engineers are in high demand due to the increasing regulation and complexity of medical devices. They play a critical role in ensuring compliance with standards like ISO 13485 and FDA requirements, and their expertise in validation, testing, and quality assurance is sought after in the healthcare industry.

What is the difference between Medical Device Validation Engineer vs Quality Assurance Engineer?

AspectMedical Device Validation EngineerQuality Assurance Engineer
CredentialsEngineering degree, certifications like CQE or validation-specific trainingEngineering or related degree, CQE or QA certifications
Work EnvironmentDesign validation, process validation, testing labsAudits, process improvements, compliance documentation
Industry UsageProduct development, validation phases in medical device manufacturingEnsuring overall product quality, compliance, and process control

The Medical Device Validation Engineer focuses on validating medical devices through testing and process validation, ensuring products meet regulatory standards. In contrast, the Quality Assurance Engineer oversees overall quality systems, audits, and compliance processes. Both roles require similar certifications and work within the medical device industry, but their core responsibilities differ in scope and focus.

What are the key skills and qualifications needed to thrive as a medical device validation engineer?

To thrive as a Medical Device Validation Engineer, you need a strong background in biomedical engineering or a related field, with expertise in validation protocols, regulatory compliance, and risk analysis. Familiarity with technical standards such as ISO 13485, FDA 21 CFR Part 820, and tools like statistical analysis software and validation management systems is essential. Attention to detail, problem-solving abilities, and effective communication are critical soft skills for collaborating with cross-functional teams and ensuring product safety. These skills are crucial to guarantee that medical devices meet regulatory requirements, function safely, and reach the market efficiently.

What are popular job titles related to Medical Device Validation Engineer jobs in Arizona?

For Medical Device Validation Engineer jobs in Arizona, the most frequently searched job titles are:

What job categories do people searching Medical Device Validation Engineer jobs in Arizona look for?

The top searched job categories for Medical Device Validation Engineer jobs in Arizona are:

What cities in Arizona are hiring for Medical Device Validation Engineer jobs?

Cities in Arizona with the most Medical Device Validation Engineer job openings:

Medical Device Validation Engineer jobs near you
Infographic showing various Medical Device Validation Engineer job openings in Arizona as of August 2026, with employment types broken down into 84% Full Time, and 16% Contract. Highlights an 100% In-person job distribution.

Hardware Validation Engineer II (Onsite)

Axon

Phoenix, AZ

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 25 days ago

Axon rating

8.8

Company rating: 8.8 out of 10

Based on 15 frontline employees who took The Breakroom Quiz

14th of 157 rated electronics manufacturers

Job description

Your ImpactAs a key member of our Validation team, you'll help ensure every product and system meets the highest standards before it reaches our customers. You'll develop Validation Test Procedures (VTPs), create comprehensive test plans, and collaborate with R&D and other teams to execute testing from start to finish. Your technical expertise will guide product evaluations, uncover issues, and drive resolutions alongside cross-functional partners. In this role, you'll work closely with Engineering, Manufacturing, Quality Assurance, Project Management, and Supply Chain-making your communication skills just as important as your technical know-how.
What You'll Do
Location: Onsite at our Deer Valley, Arizona location
Reports to: Manager, Hardware Validation & Reliability Engineering
Direct Reports: none
  • Develop comprehensive test plans for our products
  • Incorporate Statistical Analysis into Validation Testing
  • Review & provide input into System & Product Requirements.
  • Test Axon product capabilities & features to confirm requirements are met and ensure a smooth customer experience.
  • Understanding troubleshooting firmware/software or hardware issue at a system level.
  • Participate in occasional field testing of Axon products
  • Work with a team of skilled technicians to ensure timely execution of the test plans
  • Provide status updates and recommendations based on data results, and lead final reporting of validation efforts
  • Leverage Engineering background to improve tests and processes
  • Design and hone Validation Test Procedures with an emphasis on repeatability, standardization, and accuracy of testing
  • Lead and oversee execution of all validation tests - including Firmware/Software, Mechanical, Environmental, and Electrical
  • Document, track, and report test status and results to Engineering teams, following Good Documentation Practices (GDP).
  • Support Failure Analysis (FA) and Root Cause Analysis (RCA) on issues found in test
  • Work with external labs to coordinate required testing
  • Implement and maintain 5S Standard for lab organization and management
  • Develop customer usage models of all products
What You Bring
  • MS or BS Degree in Engineering, Mechanical, Electrical, Electromechanical, Reliability or equivalent.
  • Minimum of (5 years) of experience with validation or qualification testing
  • Mechanical and Environmental test experience
  • Test standards experience (MIL-STD, ISO, IEC, etc.)
  • Test automation and basic code scripting, experience.
  • Willingness to drive department improvement efforts
  • Good attention to detail and documentation
  • Experience in a regulated environment, a plus
  • Experience with identifying, reproducing, documenting, and reporting bugs or issues
  • Experience presenting test plan and requirements to stakeholders
  • Understanding of Product Development Life Cycle
  • Familiar with Project Management skill set, certified PMP a plus
  • Familiar with Bug and Test Tracking Suites such as JIRA a plus
  • Experience with manufacturing and assembly process
  • Excellent analytical and problem-solving skills
  • Excellent skills in MS Office products
  • Ability to influence multi-functional organizations
  • Certification in Six Sigma Black Belt or Green Belt ,a plus
Benefits that Benefit You
Competitive salary and 401k with employer match
Discretionary paid time off
Paid parental leave for all
Medical, Dental, Vision plans
Fitness Programs
Emotional & Mental Wellness support
Learning & Development programs
And yes, we have snacks in our offices
Benefits listed herein may vary depending on the nature of your employment and the location
where you work

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