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Validation Engineer Biomedical Jobs in California

Alphatec Spine

Validation Engineer II

Carlsbad, CA · On-site

The Validation Engineer II is a mid-level role responsible for creating, planning, and executing ... Bachelor's or master's degree in biomedical engineering or related field * 2-8 years of experience ...

Alphatec Spine

Validation Engineer II

Carlsbad, CA · On-site

The Validation Engineer II is a mid-level role responsible for creating, planning, and executing ... Bachelor's or master's degree in biomedical engineering or related field * 2-8 years of experience ...

Alphatec Spine

Validation Engineer II

Carlsbad, CA · On-site

The Validation Engineer II is a mid-level role responsible for creating, planning, and executing ... Bachelor's or master's degree in biomedical engineering or related field * 2-8 years of experience ...

Valspec

Process Validation Engineer

Oceanside, CA · On-site

$70 - $80/hr

Valspec--a global provider of system validation and lifecycle services--provides commissioning and ... Required Qualifications * BS in Chemical, Biochemical, Mechanical, or Biomedical Engineering, or a ...

Ampa, Inc.

Sr. Prototype Engineer

San Diego, CA · On-site

$75K - $90K/yr

Prior experience as a mechanical test engineer, hardware test engineer, biomedical prototype engineer, R&D lab engineer, or similar hands-on hardware testing/validation role. Why Join Ampa? * Impact:

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Validation Engineer Biomedical information

What does a validation engineer do in biomedical?

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 are the key skills and qualifications needed to thrive as a validation engineer in biomedical?

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 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.

What are popular job titles related to Validation Engineer Biomedical jobs in California?

For Validation Engineer Biomedical jobs in California, the most frequently searched job titles are:

What job categories do people searching Validation Engineer Biomedical jobs in California look for?

The top searched job categories for Validation Engineer Biomedical jobs in California are:

What cities in California are hiring for Validation Engineer Biomedical jobs?

Cities in California with the most Validation Engineer Biomedical job openings:

Validation Engineer Biomedical jobs near you
Infographic showing various Validation Engineer Biomedical job openings in California as of August 2026, with employment types broken down into 80% Full Time, and 20% Contract. Highlights an 80% In-person, and 20% Hybrid job distribution.

Process Validation Engineer

Saim Technologies

Los Angeles, CA • On-site

Other

Posted 3 days ago

New

Job description

Position: Process Validation Engineer
Location: Northridge, CA-On Site
Duration: 12+ Months Contract
Key Responsibilities
  • Develop and execute IQ/OQ/PQ protocols for critical manufacturing processes.
  • Conduct process characterization using DOE, SPC, and statistical modeling.
  • Perform process capability studies (Cp/Cpk) and implement corrective actions for lowcapability processes.
  • Define and maintain the Process Validation Master Plan (PVMP).
  • Prepare validation protocols, reports, risk assessments, PFMEAs, and process maps.
  • Support pilottoproduction scaleup for new blood glucose sensor manufacturing lines.
  • Optimize process parameters for yield, throughput, and quality.
  • Lead rootcause analysis and CAPA activities related to process deviations or excursions.
  • Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP regulations.
  • Support internal, external, and regulatory audits by providing process validation documentation.
  • Work with Manufacturing Engineering and Operations to implement validated processes on the production floor.
  • Train technicians and operators on validated processes and control plans.
Qualifications Required
  • Bachelor s degree in Biomedical, Chemical, Mechanical, Industrial, or related Engineering field.
  • 7+ years of experience in process validation within a medical device, diagnostics, or biosensor environment.
  • Strong knowledge of DOE, SPC, statistical tools (JMP/Minitab), and validation methodologies.
  • Understanding of regulated medical device manufacturing and QMS requirements.
Preferred
  • Experience with blood glucose sensor processes or electrochemical sensor manufacturing.
  • Six Sigma Green Belt or Black Belt certification.
  • Experience with automated or semiautomated process lines.

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