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Medical Device Validation Engineer Jobs (NOW HIRING)

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 ...

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

As of Jun 6, 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 reach or exceed a $500,000 annual salary, especially with experience, advanced skills, and leadership roles. Medical Device Validation Engineers typically earn less, but senior-level professionals with extensive expertise and certifications may approach high six-figure incomes in certain industries or companies.

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 May 2026, with employment types broken down into 55% Full Time, 43% Contract, and 2% Nights. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $108,152 per year, or $52 per hour.

Medical Device Validation Engineer

Tata Consultancy Service Limited

Danvers, MA • On-site

$100K - $110K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 23 days ago

Job description

Must Have Technical/Functional Skill
• Prepare TMV protocols and reports and perform Validation
• Apply Gage R&R (repeatability & reproducibility)
• Ability to select appropriate measurement tools (e.g., vernier/calipers, micrometers etc.)
Roles & Responsibilities
• Write clear TMV protocols and reports
• Create test procedures, acceptance criteria, and validation plans
• Interpret test methods, specifications, and engineering drawings
• Apply Gage R&R (repeatability & reproducibility)
• Ability to select appropriate measurement tools (e.g., vernier/calipers, micrometers etc.)
• Collaborate with Engineering, Quality, Operations, and R&D
• Produce clear, audit ready documentation to meet ISO and regulatory requirements for medical devices.
• Train operators, engineers, and quality staff on validated inspection methods and best practice
Salary Range $100,000-$110,000Per year
TCS Employee Benefits Summary:
Discretionary Annual Incentive.
Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
Family Support: Maternal & Parental Leaves.
Insurance Options: Auto & Home Insurance, Identity Theft Protection.
Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement.
Time Off: Vacation, Time Off, Sick Leave & Holidays.
Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.
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