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Medical Device Validation Engineer Jobs (NOW HIRING)

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 ...

Validation & Engineering Group, Inc

PR

Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries. * Proven experience as a Validation Engineer in a manufacturing environment. * Strong knowledge ...

Validation & Engineering Group, Inc

PR

Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries. * Proven experience as a Validation Engineer in a manufacturing environment. * Strong knowledge ...

Validation & Engineering Group, Inc

PR

Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries. * Proven experience as a Validation Engineer in a manufacturing environment. * Strong knowledge ...

Validation & Engineering Group, Inc

PR

Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries. * Proven experience as a Validation Engineer in a manufacturing environment. * Strong knowledge ...

Validation & Engineering Group, Inc

PR

Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries. * Proven experience as a Validation Engineer in a manufacturing environment. * Strong knowledge ...

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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 Jun 27, 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.

What engineers make $500,000?

Senior engineers in specialized fields such as petroleum, aerospace, or software engineering can earn $500,000 or more annually, often through a combination of base salary, bonuses, and stock options. Achieving this level typically requires extensive experience, advanced skills, and sometimes leadership roles or working in high-paying industries.

How much does a validation engineer make at Pfizer?

A validation engineer at Pfizer typically earns between $70,000 and $100,000 annually, depending on experience, location, and certifications. Salaries may also include benefits such as health insurance and bonuses, with some roles requiring knowledge of validation protocols and regulatory standards.

Do validation engineers make good money?

Validation engineers, including those in the medical device industry, typically earn competitive salaries that reflect their specialized skills in quality assurance, regulatory compliance, and testing. Salaries vary based on experience, location, and certifications such as GxP or ISO standards, but generally offer strong compensation compared to many entry-level roles. The profession often includes benefits like healthcare and opportunities for career advancement.

What engineers make $300,000 a year?

Senior medical device validation engineers with extensive experience, specialized skills in quality assurance, and certifications such as ISO 13485 can reach annual salaries of $300,000 or more. These roles often require advanced knowledge of regulatory standards, validation processes, and proficiency with testing tools in highly regulated environments.

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, and why are they important?

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 June 2026, with employment types broken down into 100% Full Time. Highlights an 88% Physical, 4% Hybrid, and 8% Remote job distribution, with an average salary of $108,152 per year, or $52 per hour.
Validation Engineer (Medical Device)

Validation Engineer (Medical Device)

Scalable Systems

San Diego, CA • On-site

Other

Posted 2 days ago

Job description

Scalable Systems is a USA based Big Data, Analytics and Digital Transformation company focused on vertical specific innovative solutions. By providing next generation technology solutions and services, we help organizations to identify risks & opportunities, achieve operational excellence and to gain an innovative edge.

Job Role – Validation Engineer (Medical Device)
Location – San Diego, CA (Day 1 Onsite)
Role Descriptions: Must Have Technical/Functional Skills

Must-Have Skills

· Strong expertise in V&V for medical devices

· Hands-on experience in:

o Protocol writing (IQ, OQ, PQ, CSV, system validation)

o Validation execution and reporting

· Deep understanding of:

o FDA regulations (21 CFR Part 820)

o ISO 13485 standards

o Risk management (ISO 14971)

· Experience in regulated environments with minimal supervision

· Ability to independently manage multiple protocols simultaneously

Preferred Skills

· Experience with complex medical systems (e.g., imaging systems, surgical systems, or similar platforms like Elita)

· Exposure to software validation / computerized system validation (CSV)

· Prior experience in large-scale validation programs (100+ protocols) · Strong documentation and audit readiness experience · Familiarity with tools like: o TrackWise / Veeva / ETQ (or similar QMS systems) Experience Requirement · 8–12+ years in V&V within the medical device industry · Proven experience working as a Subject Matter Expert (SME) · Prior experience working in onsite client environments in the US is a strong plus · Expat profiles are acceptable Candidate Profile · Self-driven and capable of working independently with minimal guidance · Strong ownership mindset with execution focus · Excellent communication and stakeholder management skills · Comfortable working under tight timelines and immediate onboarding expectations

Roles & Responsibilities

Role Overview:

We are looking for experienced Validation & Verification (V&V) experts to support protocol development and execution for the Elita system. The role requires independent ownership of end-to-end V&V activities with minimal onboarding or training.

The candidate will contribute toward executing approximately 150–170 validation protocols within a defined timeline

Key Responsibilities:

· Independently author, review, and execute V&V protocols (IQ/OQ/PQ, system validation, software validation, etc.)

· Ensure all validation activities comply with regulatory standards (FDA, ISO 13485, 21 CFR Part 820)

· Drive end-to-end protocol lifecycle, including:

o Protocol authoring

o Test execution

o Documentation and reporting

o Defect tracking and resolution

· Collaborate with cross-functional teams (R&D, Quality, Manufacturing, Regulatory)

· Provide SME-level inputs for validation strategy and risk-based validation approaches

· Support audit readiness and documentation for regulatory inspections

· Work in a high-paced environment with immediate delivery expectations

Generic Managerial Skills, If any

1. Leadership

2. Communication Skills

3. Stakeholder Management

4. Decision Making

5. Problem Solving

6. Mentoring & Coaching

7. Conflict Resolution

8. Strategic Thinking

9. Time & Priority Management

10. Adaptability & Flexibility

Desirable Skills:

Keyword:

Skills: ISO 13485~EIS : Medical Device & Regulations Experience Required: 10 & Above

Scalable Systems is an Equal Opportunity-Affirmative Action Employer - Minority / Female / Disability / Veteran / Gender Identity / Sexual Orientation

Apply