{"schemaVersion":"jobsearcher.job.v1","id":"e518d8b1213ac9d2a04a00df","url":"https://jobsearcher.com/jobs/e518d8b1213ac9d2a04a00df","canonicalUrl":"https://jobsearcher.com/jobs/e518d8b1213ac9d2a04a00df","title":"Lead Validation Engineer","description":"Job Title: Lead Validation EngineerExperience: 8 - 10 yearsLocation: San Jose, CA, USAEducation: Bachelor of Science in Engineering, B.E. / B.Tech. Mechanical Engineering, M.S. Mechanical EngineeringExperience Requirements:Minimum 6 years of relevant experience in medical device manufacturing.Experience working in a clean room environment.Experience with Test Method Validation and/or Measurement System Analysis is preferred.Knowledge of computer software for data analysis, specifically Microsoft Excel and statistical packages (Minitab preferred), is a plus.Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485.Strong organizational skills and detail-oriented.Ability to collaborate within an organization across all functional departments (e.g., Legal, Regulatory, Operations, Procurement, Clinical Affairs, Operations, Marketing, Quality, etc.).Ability to work to a deadline and handle multiple tasks simultaneously.Proficiency in Microsoft Office, including Microsoft Word, Excel, and PowerPoint.Experience with 3D CAD Software SolidWorks.Experience working with Engineering change management software and releasing engineering change orders.Job Duties:Process and equipment qualification (IQ/OQ/PQ).Development of test methods for Design Verification & Validation (V&V), Process Validation, and Production.Validation of test methods.Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work.Authoring/releasing new test methods and editing/redlining old test methods.Experience working in a regulated and/or medical device environment.Defining equipment requirements.Drafting equipment specifications.Working on change management and releasing engineering change orders.Designing process validations and identifying critical process parameters related to equipment.","company":"Addsource","rawCompany":"addsource","city":"California","state":"MO","isRemote":false,"isActive":false,"createdAt":"2026-08-14T11:10:02.655Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2141.00","title":"Mechanical Engineers","slug":"mechanical-engineers"},{"code":"17-2031.00","title":"Bioengineers and Biomedical Engineers","slug":"bioengineers-and-biomedical-engineers"}],"industries":[{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Lead Validation Engineer","description":"Job Title: Lead Validation EngineerExperience: 8 - 10 yearsLocation: San Jose, CA, USAEducation: Bachelor of Science in Engineering, B.E. / B.Tech. Mechanical Engineering, M.S. Mechanical EngineeringExperience Requirements:Minimum 6 years of relevant experience in medical device manufacturing.Experience working in a clean room environment.Experience with Test Method Validation and/or Measurement System Analysis is preferred.Knowledge of computer software for data analysis, specifically Microsoft Excel and statistical packages (Minitab preferred), is a plus.Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485.Strong organizational skills and detail-oriented.Ability to collaborate within an organization across all functional departments (e.g., Legal, Regulatory, Operations, Procurement, Clinical Affairs, Operations, Marketing, Quality, etc.).Ability to work to a deadline and handle multiple tasks simultaneously.Proficiency in Microsoft Office, including Microsoft Word, Excel, and PowerPoint.Experience with 3D CAD Software SolidWorks.Experience working with Engineering change management software and releasing engineering change orders.Job Duties:Process and equipment qualification (IQ/OQ/PQ).Development of test methods for Design Verification & Validation (V&V), Process Validation, and Production.Validation of test methods.Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work.Authoring/releasing new test methods and editing/redlining old test methods.Experience working in a regulated and/or medical device environment.Defining equipment requirements.Drafting equipment specifications.Working on change management and releasing engineering change orders.Designing process validations and identifying critical process parameters related to equipment.","datePosted":"2026-08-14T11:10:02.655Z","dateModified":"2026-08-14T11:10:02.655Z","hiringOrganization":{"@type":"Organization","name":"Addsource","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"California","addressRegion":"MO","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"e518d8b1213ac9d2a04a00df"},"url":"https://jobsearcher.com/jobs/e518d8b1213ac9d2a04a00df"}}