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Medical Device Validation Engineer Jobs in Arizona

Hanger, Inc.

QA/QC Engineer II

Phoenix, AZ

$71K - $92K/yr

Perform validation activities including IQ, OQ, and PQ processes according to 21 CFR 820 and 21 CFR ... Experience in manufacturing of medical device with electronic components is preferred. * Broad ...

Hanger, Inc.

QA/QC Engineer II

Phoenix, AZ · On-site

$71K - $92K/yr

Perform validation activities including IQ, OQ, and PQ processes according to 21 CFR 820 and 21 CFR ... Experience in manufacturing of medical device with electronic components is preferred. * Broad ...

AbbVie

Associate Director, Engineering

Tempe, AZ

In addition, the role provides leadership and direction for all Medical Device performance related ... validation through retirement. * Directs GMP and non-GMP equipment, facility and utility projects ...

Ziehm Orthoscan

Senior Software Engineer

Scottsdale, AZ

$123K - $163K/yr

As a Senior Software Engineer, you will be developing primarily C++ applications for medical ... validate software solutions for our C-Arm (Linux based computer) in compliance with medical device ...

Orthoscan, Inc.

Senior Software Engineer

Scottsdale, AZ · On-site

$120 - $170/hr

As a Senior Software Engineer, you will be developing primarily C++ applications for medical ... validate software solutions for our C-Arm (Linux based computer) in compliance with medical device ...

AbbVie

Associate Director, Engineering

Tempe, AZ · On-site

$141K/yr

In addition, the role provides leadership and direction for all Medical Device performance related ... validation through retirement. * Directs GMP and non-GMP equipment, facility and utility projects ...

AbbVie

Associate Director, Engineering

Tempe, AZ

In addition, the role provides leadership and direction for all Medical Device performance related ... validation through retirement. * Directs GMP and non-GMP equipment, facility and utility projects ...

Ziehm Orthoscan

Senior Software Engineer

Scottsdale, AZ · On-site

$123K - $162K/yr

As a Senior Software Engineer, you will be developing primarily C++ applications for medical ... validate software solutions for our C-Arm (Linux based computer) in compliance with medical device ...

Orthoscan, Inc.

Senior Software Engineer

Scottsdale, AZ · On-site

$123K - $163K/yr

As a Senior Software Engineer, you will be developing primarily C++ applications for medical ... validate software solutions for our C-Arm (Linux based computer) in compliance with medical device ...

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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.

Sr. R&D Engineer- Relocation Assistance Provided

Innovative Health

Scottsdale, AZ

$105K - $144K/yr

Full-time

Posted 11 days ago

Job description

The Senior R&D Engineer role is responsible for designing, developing, validating, and implementing various methods and processes, leading and assisting in projects to introduce new products into production. This role is expected to bring unique perspectives and creative solutions to challenges faced during reverse engineering and reprocessing technique development.

Essential Duties and Responsibilities:

• Assist and/or lead in development of new medical device platforms complying with design control process including applicable FDA and ISO requirements.

• Develop, write, and execute test methods.

• Train manufacturing/QC personnel as needed on test methods or manufacturing processes.

• Generate formal test protocols and reports.

• Execute test protocols and conduct bench testing. Document test results per GDP, ISO, and FDA requirements.

• Coordinate and oversee test sample builds. Assist with test sample builds as required.

• Use Solidworks to design test fixtures and devices. (if applicable)

• Design and fabricate test fixtures, tooling and equipment. (if applicable)

• Work with purchasing department to specify and procure capital equipment.

• Serve as a cross-functional team member for various project-related activities.

• Assist or lead process improvement projects to reduce costs.

• Assist with DFMEA and PFMEA risk assessments.

• Compile project status updates and present to senior management.

• Comply with company policies and procedures.

• Maintain project schedule and deliver projects on time.

• Focus on delivering products to support the R&D project pipeline.

• Provide technical leadership to junior engineers and technicians.

Clinical Support Responsibilities:

• Attend clinical cases for learning, device launch, and troubleshooting.

• Interact with clinicians and field personnel to understand clinical needs and provide technical support.

• Develop and maintain a deep understanding of medical device reprocessing techniques, including cleaning, sterilization, and biocompatibility requirements.

• Develop and maintain relationships with key opinion leaders and clinical partners.

Medical Device Reprocessing Responsibilities:

• Develop and optimize reprocessing methods for single-use medical devices.

• Conduct performance, biocompatibility and sterilization testing on reprocessed devices.

• Ensure compliance with all regulatory requirements for medical device reprocessing.

• Participate in cross-functional teams to introduce reprocessed devices into production.

Supervisory Responsibilities:

· Provide mentoring and guidance to other R&D team members, as well as supervise and manage the work of junior engineers.

Education, Qualifications and Skills:

· Minimum education: Bachelor's degree in engineering discipline (or equivalent experience)

· Minimum experience: 7-12 years of experience

· Strong background in R&D with experience in electromechanical medical devices.

· Experience with various types of medical device design verification testing in accordance with FDA regulations: device functional performance, biocompatibility, sterilization, packaging, transportation simulation, real-time and accelerated aging, etc.

· Excellent technical writing skills and substantial experience writing test plans, protocols, and reports.

· Excellent problem-solving skills as well as keen analytical abilities.

· Knowledge of Design Controls, Risk Management, Statistics, Engineering Principles, Test Method Development, Test Method Validation (Gage R&R), and Design Verification / Validation.

· Proficiency in CAD design and drafting (SolidWorks) a plus.

· Ability to work in a fast-paced, collaborative team environment.

· Strong hands-on prototyping skills.

· Self-starter and highly motivated.

· Ability to have fun by motivating and encouraging other team members.

Apply