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Medical Device Validation Engineer Jobs in Boston, MA

Tekhawks LLC

Be Seen First

Associate Validation Engineer - Mechanical Focus - Med Device

Danvers, MA · On-site

$40 - $45/hr

Air Quality Visual Inspection Air Filtration Water Filtration Position Summary Seeking an Associate Validation Engineer to support medical device validation activities within a manufacturing and ...

New

Tekhawks LLC

Be Seen First

Associate Validation Engineer - Mechanical Focus - Med Device

Danvers, MA · On-site

$40 - $45/hr

Air Quality Visual Inspection Air Filtration Water Filtration Position Summary Seeking an Associate Validation Engineer to support medical device validation activities within a manufacturing and ...

New

Initial Therapeutics, Inc.

Validation Engineer

Boston, MA · On-site

$80 - $100/hr

The Validation Engineer will be responsible for driving overall quality performance and compliance ... or medical device industry. * Knowledge and experience working with FDA cGMP, FMEA, and Risk ...

Syner-G

Validation Engineer

Boston, MA · On-site +1

The Validation Engineer will be responsible for driving overall quality performance and compliance ... or medical device industry. * Knowledge and experience working with FDA cGMP, FMEA, and Risk ...

Syner-G

Validation Engineer

Boston, MA · On-site

The Validation Engineer will be responsible for driving overall quality performance and compliance ... or medical device industry. * Knowledge and experience working with FDA cGMP, FMEA, and Risk ...

Syner-G

Validation Engineer

Boston, MA · On-site

The Validation Engineer will be responsible for driving overall quality performance and compliance ... or medical device industry. * Knowledge and experience working with FDA cGMP, FMEA, and Risk ...

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All JobsMedical Device Validation Engineer JobsMedical Device Validation Engineer Jobs in Boston, MA

Medical Device Validation Engineer information

See Boston, MA salary details

$24

$56

$84

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

As of Aug 26, 2026, the average hourly pay for medical device validation engineer in Boston, MA is $56.49, according to ZipRecruiter salary data. Most workers in this role earn between $42.84 and $68.70 per hour, depending on experience, location, and employer.

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 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 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 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 popular job titles related to Medical Device Validation Engineer jobs in Boston, MA?

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

What job categories do people searching Medical Device Validation Engineer jobs in Boston, MA look for?

The top searched job categories for Medical Device Validation Engineer jobs in Boston, MA are:

What cities near Boston, MA are hiring for Medical Device Validation Engineer jobs?

Cities near Boston, MA 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 Boston, MA as of June 2026, with employment types broken down into 94% Full Time, 3% Contract, and 3% Nights. Highlights an 88% Physical, 4% Hybrid, and 8% Remote job distribution, with an average salary of $117,497 per year, or $56.5 per hour.

Associate Validation Engineer - Mechanical Focus - Med Device

Tekhawks LLC

Danvers, MA • On-site

$40 - $45/hr

Contractor

Posted yesterday

New

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Job description

Associate Validation Engineer  Mechanical Focus

Location: Danvers, MA

Schedule: 100% Onsite


These are the top requirements:

Air Quality
Visual Inspection
Air Filtration
Water Filtration


Position Summary

Seeking an Associate Validation Engineer to support medical device validation activities within a manufacturing and remediation environment. This role will support process validation, test method validation, inspection validation, and equipment qualification activities while working closely with Quality, Engineering, Manufacturing, and Operations teams.

The ideal candidate will possess a strong engineering foundation (Electrical or Mechanical) along with hands-on experience supporting validation activities within a regulated medical device environment.


Responsibilities

  • Execute IQ, OQ, and PQ protocols
  • Support process validation and equipment qualification activities
  • Develop and execute test method validation (TMV) protocols
  • Support inspection method validation activities
  • Assist with validation protocol generation, execution, and reporting
  • Support root cause investigations associated with validation activities
  • Review and analyze validation data
  • Collaborate with Quality, Manufacturing, and Engineering teams
  • Support remediation and continuous improvement initiatives
  • Maintain validation documentation in accordance with FDA and ISO requirements


Required Qualifications

  • Bachelor's degree in Engineering (Electrical or Mechanical preferred)
  • 5-8 years of medical device validation experience
  • Experience with:
    • IQ/OQ/PQ
    • Process Validation
    • Test Method Validation (TMV)
    • Inspection Method Validation
  • Working knowledge of FDA Quality System requirements
  • Strong technical writing and documentation skills


Mechanical Opening

  • Mechanical Engineering background
  • Manufacturing process validation experience
  • Prior soldering experience
  • Assembly process validation