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Validation Engineer Medical Devices Jobs (NOW HIRING)

Alphatec Spine

Validation Engineer II

Carlsbad, CA

The Validation Engineer II supports a broad range of software-enabled medical devices within a product suite that includes intraoperative neuromonitoring, surgical alignment, robotic navigation, and ...

Flex

Controls Engineer - Medical Devices

Austin, TX · On-site

$82K - $107K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

... of medical devices. This role supports production uptime, equipment reliability, product quality ... Support validation and implementation of new vision inspection applications. Collaboration with ...

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

As of Aug 15, 2026, the average hourly pay for validation engineer medical devices 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 is a validation engineer medical devices?

A Validation Engineer in medical devices ensures that products, processes, and equipment meet regulatory and quality standards. They develop and execute validation protocols, conduct tests, analyze data, and document results to ensure compliance with FDA, ISO 13485, and other regulations. Their role is crucial in verifying that medical devices are safe, effective, and consistent in performance before they reach the market.

What are some typical challenges faced by validation engineers in the medical device industry?

Validation Engineers in the medical device industry often encounter challenges such as navigating ever-evolving regulatory standards, managing tight project timelines, and ensuring thorough documentation for audits. They are frequently tasked with balancing the need for comprehensive testing and validation with efficiency to support product development cycles. Working closely with cross-functional teams—including design, quality assurance, and manufacturing—requires strong collaboration and adaptability. Overcoming these challenges helps ensure that medical devices are safe, effective, and compliant with industry regulations, making the role both demanding and highly impactful.

What are the key skills and qualifications needed to thrive as a validation engineer medical devices?

A Validation Engineer in Medical Devices needs a strong background in biomedical engineering or a related field, knowledge of regulatory requirements (such as FDA or ISO 13485), and expertise in validation methodologies. Familiarity with tools like statistical analysis software, quality management systems (QMS), and documentation platforms is often required, as well as certifications such as CQE (Certified Quality Engineer). Strong attention to detail, problem-solving abilities, and effective communication skills are essential to excel in this role. These competencies are critical to ensure medical devices meet rigorous safety and compliance standards, protecting patient health and supporting successful product launches.

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Validation Engineer Medical Devices jobs near you
Infographic showing various Validation Engineer Medical Devices job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $108,152 per year, or $52 per hour.

Senior Validation Engineer - Medical Devices

Stark Pharma Solutions Inc

Silver Spring, MD • On-site

Contractor

Re-posted 11 days ago

Job description

Job Title: Senior Validation Engineer – Medical Devices

Location: Silver Spring, MD (Onsite)

Duration: 06 months contract (High potential for extension)

Job Summary

We are seeking a Senior Validation Engineer to support equipment lifecycle management, facility changes, and commercialization activities within a medical device environment. This role will play a key part in ensuring equipment and systems are validated, compliant, and maintained in a validated state throughout their lifecycle.

The ideal candidate will have strong experience in validation documentation, equipment qualification, and cross-functional collaboration within regulated environments.

Key Responsibilities

Validation & Documentation

  • Develop, review, and execute validation documents including:
    • User Requirement Specifications (URS)
    • Validation Determination Assessments (VDA)
    • Installation, Operational, and Performance Qualifications (IQ/OQ/PQ)
    • Requirements Traceability Matrix (RTM)
    • Final/Summary Reports
  • Support equipment lifecycle validation activities for commercial medical device operations
  • Execute validation protocols and ensure compliance with regulatory standards

Required Qualifications

  • Minimum 5+ years of experience in validation within medical device or regulated environments
  • Strong experience with equipment lifecycle management and validation documentation
  • Hands-on experience with IQ/OQ/PQ, URS, RTM, and validation reporting
  • Experience supporting commercialization, facility changes, or system transitions
  • Knowledge of GMP, FDA, and quality system requirements
  • Strong collaboration, communication, and problem-solving skills