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Medical Device Validation Engineer Jobs in Massachusetts

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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Medical Device Validation Engineer information

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 Massachusetts?

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

What job categories do people searching Medical Device Validation Engineer jobs in Massachusetts look for?

The top searched job categories for Medical Device Validation Engineer jobs in Massachusetts are:

What cities in Massachusetts are hiring for Medical Device Validation Engineer jobs?

Cities in Massachusetts 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 Massachusetts as of August 2026, with employment types broken down into 1% As Needed, 75% Full Time, 16% Part Time, 1% Temporary, 6% Contract, and 1% Nights. Highlights an 87% Physical, 1% Hybrid, and 12% Remote job distribution.

Process Validation Engineer/Manufacturing Engineer - Medical Device

Stark Pharma Solutions Inc

Raynham, MA • On-site

Contractor

Re-posted 26 days ago

Job description

Job Title: Senior Process Validation Engineer

Location: Raynham, MA (Onsite – Local candidates preferred)

Type: Contract (1 year + long-term extensions)

Industry: Medical Device Manufacturing | Supply Chain Quality

Job Summary:

We are seeking a Senior Process Validation Engineer to support the startup and qualification of a new Class III medical device manufacturing facility. This role will be part of the Supply Chain Quality team and will lead critical validation and quality activities to ensure compliant and efficient manufacturing operations.

The ideal candidate will bring strong expertise in process validation, equipment qualification, and inspection readiness, working closely with cross-functional teams in a highly regulated environment.

Key Responsibilities

  • Lead process qualification and validation activities to ensure manufacturing processes are robust and compliant
  • Plan and execute IQ, OQ, PQ, and process validation activities
  • Develop validation strategies, protocols, reports, and documentation (including URS)
  • Support inspection readiness by ensuring Critical-to-Quality (CTQ) characteristics are verified using qualified methods
  • Perform test method validation and measurement system analysis (e.g., Gauge R&R)
  • Provide Quality oversight for validation documentation and approvals
  • Support deviation investigations, root cause analysis, and troubleshooting
  • Collaborate with Manufacturing, Engineering, Supply Chain, and R&D teams to meet project timelines

Required Qualifications

  • 5+ years of hands-on experience in process validation within regulated environments (GMP/ISO)
  • 4+ years of experience in Quality, Supply Chain, or R&D within medical devices or similar industries
  • Strong expertise in IQ/OQ/PQ, process verification, and validation documentation
  • Experience with CNC machining processes and Coordinate Measuring Machines (CMM)
  • Experience in risk management (FMEA)
  • Strong communication, collaboration, and project management skills