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Medical Device Validation Engineer Jobs (NOW HIRING)

Marquee Staffing - OC

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Medical Device Validation Engineer (Onsite)

Cypress, CA · On-site

$40 - $55/hr

... transforming medical device organization. This role sits at the intersection of engineering ... Software Validation & Lifecycle Management * Develop and execute validation plans for non-product ...

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Intellectt INC

Validation Engineer

San Diego, CA · On-site

Validation Engineer Location: San Diego, CA Duration: Longterm Job Summary: A Validation Engineer ... Strong experience in medical device validation, including IQ/OQ/PQ, process validation, facility ...

Intellectt INC

The Automation Validation Engineer will be responsible for validating automation systems and ensuring compliance with regulatory and industry standards within a medical device environment. Key ...

Intellectt INC

Validation Engineer II

Carlsbad, CA · On-site

Validation Engineer II Location: Carlsbad, CA Type: W2 Contract Industry: Medical Devices / Heal ... Experience in Medical Device or regulated manufacturing * Knowledge of Validation Lifecycle ...

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Medical Device Validation Engineer information

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How much do medical device validation engineer jobs pay per hour?

As of Aug 7, 2026, the average hourly pay for medical device validation engineer in the United States is $52.00, according to ZipRecruiter salary data. Most workers in this role earn between $39.42 and $63.22 per hour, depending on experience, location, and employer.

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.
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Medical Device Validation Engineer jobs near you
Infographic showing various Medical Device Validation Engineer job openings in the United States as of August 2026, with employment types broken down into 61% Full Time, 6% Temporary, and 33% Contract. Highlights an 94% In-person, and 6% Remote job distribution, with an average salary of $108,152 per year, or $52 per hour.

Medical Device Validation Engineer (Onsite)

Marquee Staffing - OC

Cypress, CA • On-site

$40 - $55/hr

Full-time

Medical, Dental, Vision

Posted 2 days ago

New

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Job description

Position Summary

We are seeking a proactive, results-driven, and versatile Solutions Engineer to lead strategic technical initiatives across manufacturing operations in a fast-paced, digitally transforming medical device organization. This role sits at the intersection of engineering, digital systems, and operations, combining leadership in project management, requirements engineering, and software validation with a strong commitment to Lean, Agile, and Six Sigma principles to develop and deploy validated, scalable solutions.

Key Responsibilities

Systems Requirements & Engineering

  • Lead end-to-end execution of cross-functional operations and engineering projects from scoping and planning through deployment and post-launch support across multiple sites and functions.
  • Develop project plans, timelines, resource strategies, risk registers, and project documentation to deliver validated, audit-ready solutions.
  • Elicit and translate operational, business, and user requirements into functional and technical specifications.
  • Define architecture, interfaces, and integration points for new and legacy systems, including integrated hardware, software, and processes supporting manufacturing operations.

Risk & Compliance Management

  • Conduct and document technical risk assessments (e.g., FMEA, software risk) aligned with ISO 14971.
  • Ensure system implementations and changes meet ISO 13485, 21 CFR Part 820/11, and internal operating procedures.

Software Validation & Lifecycle Management

  • Develop and execute validation plans for non-product software used in manufacturing and quality processes.
  • Collaborate with IT, Systems, QA, and functional owners to ensure validated systems remain compliant through upgrades and change control.

Qualifications

  • Bachelor’s or Master’s degree in Engineering (Systems, Software, or another related technical field).
  • Experience developing AWS-based solutions and front-end and/or back-end software development is a plus.
  • 3–5 years of experience in a medical device manufacturing environment, operations engineering, or other regulated manufacturing environment.
  • Strong knowledge of ISO 14971, ISO 13485, 21 CFR Part 11/820, and IEC 62304.
  • Proven track record delivering validated systems that support production, traceability, and business/compliance objectives.
  • Demonstrated ability to thrive in rapidly evolving environments with shifting priorities and emerging technologies.
  • Ability to manage multiple priorities within demanding timeframes.
  • Direct experience in systems verification & validation (V&V) activities within the medical device industry.
  • Demonstrated experience in project planning, systems integration, and cross-functional technical leadership.

Company Description

Marquee Staffing has built a reputation on expert local market knowledge, unparalleled personalized service and the ability to deliver winning candidates and job opportunities.

Marquee operates offices located conveniently throughout Southern California. Each branch is full-service, providing temporary, contract, contract-to-hire and direct placement services for a diverse set of clients. Each branch has recruiters who specialize in key industries, ensuring that our clients get the best match possible for each open position and that our candidates get expert guidance in their career path.

Apply with us today!