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Validation Engineer Biomedical Jobs (NOW HIRING)

Smith & Nephew

Software Validation Engineer 2

Austin, TX · On-site

$70K - $105K/yr

Mechanical, Chemical or Biomedical Engineering degree preferred with minimum 2 years of experience either in a pharmaceutical or orthopedic environment, performing routine validation and testing ...

Jj

Principal R&D Validation Engineer

Irvine, CA · On-site

Biomedical Engineering Job Category: Scientific/Technology All Job Posting Locations: Irvine ... The Principal R&D Validation Engineer leads the technical strategy and execution for advanced ...

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How much do validation engineer biomedical jobs pay per hour?

As of Jun 4, 2026, the average hourly pay for validation engineer biomedical 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 the key skills and qualifications needed to thrive as a Validation Engineer in Biomedical, and why are they important?

To thrive as a Validation Engineer in Biomedical, you need a solid background in engineering or life sciences, knowledge of regulatory standards (such as FDA or ISO 13485), and experience with validation protocols. Familiarity with technical tools like statistical analysis software, calibration equipment, and documentation systems is essential, and certifications such as Six Sigma or CQE can be advantageous. Strong problem-solving, attention to detail, and effective communication skills help you excel in cross-functional teams and ensure compliance. These skills are crucial for maintaining product quality, meeting regulatory requirements, and ensuring patient safety in biomedical environments.

What are some typical challenges faced by Validation Engineers in the biomedical industry and how can they be addressed?

Validation Engineers in the biomedical field often face challenges such as keeping up with evolving regulatory requirements, managing complex documentation, and ensuring equipment or processes meet stringent quality standards. Navigating audits and working cross-functionally with R&D, manufacturing, and quality assurance teams can also be demanding. To address these challenges, staying current with industry regulations, developing strong organizational and communication skills, and maintaining meticulous records are essential for success and career growth in this role.

What does a Validation Engineer do in the biomedical field?

A Validation Engineer in the biomedical industry ensures that equipment, processes, and systems used in the production of medical devices or pharmaceuticals meet regulatory standards and function as intended. Their work involves planning and executing validation protocols, documenting results, and troubleshooting any deviations. This role is crucial for maintaining product quality, patient safety, and compliance with regulatory agencies such as the FDA. Validation Engineers often collaborate with quality assurance, manufacturing, and research teams to establish and maintain validated systems throughout a product's lifecycle.

What is the difference between Validation Engineer Biomedical vs Quality Assurance Engineer Biomedical?

AspectValidation Engineer BiomedicalQuality Assurance Engineer Biomedical
CertificationsGMP, ISO, FDA validation certificationsGMP, ISO, audit and compliance certifications
Work EnvironmentDesign, develop, and execute validation protocols for medical devicesDevelop and maintain quality systems, audits, and process improvements
Industry UsagePrimarily in medical device manufacturing and regulatory validationAcross medical device, pharmaceutical, and biotech industries

Validation Engineer Biomedical focuses on ensuring medical devices meet regulatory validation requirements through testing and protocols. Quality Assurance Engineer Biomedical emphasizes maintaining quality systems, compliance, and process improvements. Both roles are essential in the biomedical industry but serve different functions related to validation versus quality assurance.

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Validation Engineer Biomedical jobs near you
Infographic showing various Validation Engineer Biomedical job openings in the United States as of May 2026, with employment types broken down into 99% Full Time, and 1% Part Time. Highlights an 86% Physical, 2% Hybrid, and 12% Remote job distribution, with an average salary of $108,152 per year, or $52 per hour.

Verification and Validation Engineer

Vital Bio

Oakville, CA

Full-time

Posted 20 days ago

Job description

Description
About You:

You possess excellent problem-solving skills and approach every problem with a friendly and positive attitude. You are self-motivated, possess a high level of autonomy, and enjoy working in a highly technical, fast-paced, and multidisciplinary environment. You take ownership of a problem and seek additional information where sufficient input is lacking to proceed with testing and see the problem through to resolution. You take pride in making things work and seeing others effectively use what you worked on.

What You’ll Do:
  • Take ownership of various design verification activities;
  • Design, develop, and execute test plans and procedures;
  • Work closely with the R&D, Engineering, and Quality teams to create a robust test suite;
  • Complete documentation for results and reports;
  • Use exploratory test techniques to provide early testing feedback throughout the design and development process;
  • Design and develop methods and test tools, manual and automated, to aid in efficient and systematic testing;
  • Demonstrated use of reliability and quality engineering methods and tools – DFMEA, life data analysis, reliability testing, statistical analyses, etc;
  • Participate in design reviews to assess design verification and validation impact;
  • Accurately report and track product defects, verify hardware bug fixes, and perform regression testing;
  • Help generate manufacturing instructions and associated in-process test methods, where necessary;
  • Manage test equipment to comply with calibration requirements and perform inspection on equipment.

What You’ll Need:
  • Bachelor’s or Master's degree in Electrical Engineering, Mechatronics Engineering, Biomedical Engineering or equivalent;
  • 3+ years of related experience;
  • 2+ years of professional experience in a team working on new product development;
  • Experience in a regulated industry (specifically medical and aerospace);
  • Hands-on expertise with electrical test and measurement equipment: oscilloscopes (voltage/current/power), multimeters, signal generators, optical systems, computer vision, machine learning;
  • Advanced level analytical programming (Python, Matlab, etc.).
Bonus points for:
  • Experience developing/testing/production of IVD devices;
  • Experience designing specialized electro-mechanical and optomechanical test fixtures;
  • Scripted automated testing (e.g., using Python or JavaScript with Test and Measurement equipment);
  • Familiarity with CAD software (SolidWorks), prototyping equipment (CNC, 3D printing, laser cutter), and general machine shop experience;
  • Knowledge of the following standards: IEC 60601, ISO 13485, ISO 14971;
  • Experience with the medical device product development lifecycle;
  • Appreciation of puns!
Compensation will be determined based on the individual’s demonstrated experience, education, training, relevant certifications or licensure, and other applicable business and organizational factors.
This role is a current, onsite vacancy.