{"schemaVersion":"jobsearcher.job.v1","id":"a1029ca97361aef707dc10de","url":"https://jobsearcher.com/jobs/a1029ca97361aef707dc10de","canonicalUrl":"https://jobsearcher.com/jobs/a1029ca97361aef707dc10de","title":"Systems Engineer Medical Device | Remote","description":"We are seeking experienced Systems Engineers to support Design History File (DHF) remediation and gap assessment activities for a medical device program.Key Responsibilities: Perform system-level gap assessments across requirements, architecture, traceability, and V&V documentation Review Design Inputs, Design Outputs, Verification & Validation, and Risk Management documentation Develop or remediate system specifications, interface requirements, and risk analysis documents Support V&V planning and traceability matrix updates Resolve subsystem integration and design control gaps Collaborate with Hardware, Software, Quality, Clinical, Regulatory, and Manufacturing teamsRequired Qualifications: Systems Engineering experience Medical Device development background Design Controls and Traceability expertise Knowledge of ISO 13485, ISO 14971, and 21 CFR 820 Risk Management and V&V Planning experience Strong documentation and remediation experiencePreferred: DHF Remediation projects Gap Assessment experience Electro-mechanical and Software-enabled Medical DevicesInterested candidates can message me directly or send their updated resume.","company":"Intellectt","rawCompany":"intellectt","isRemote":true,"isActive":false,"createdAt":"2026-06-05T11:46:10.418Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"15-1299.08","title":"Computer Systems Engineers/Architects","slug":"computer-systems-engineers-architects"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"}],"industries":[{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"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"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Systems Engineer Medical Device | Remote","description":"We are seeking experienced Systems Engineers to support Design History File (DHF) remediation and gap assessment activities for a medical device program.Key Responsibilities: Perform system-level gap assessments across requirements, architecture, traceability, and V&V documentation Review Design Inputs, Design Outputs, Verification & Validation, and Risk Management documentation Develop or remediate system specifications, interface requirements, and risk analysis documents Support V&V planning and traceability matrix updates Resolve subsystem integration and design control gaps Collaborate with Hardware, Software, Quality, Clinical, Regulatory, and Manufacturing teamsRequired Qualifications: Systems Engineering experience Medical Device development background Design Controls and Traceability expertise Knowledge of ISO 13485, ISO 14971, and 21 CFR 820 Risk Management and V&V Planning experience Strong documentation and remediation experiencePreferred: DHF Remediation projects Gap Assessment experience Electro-mechanical and Software-enabled Medical DevicesInterested candidates can message me directly or send their updated resume.","datePosted":"2026-06-05T11:46:10.418Z","dateModified":"2026-06-05T11:46:10.418Z","hiringOrganization":{"@type":"Organization","name":"Intellectt","sameAs":"https://jobsearcher.com"},"jobLocationType":"TELECOMMUTE","applicantLocationRequirements":{"@type":"Country","name":"US"},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"a1029ca97361aef707dc10de"},"url":"https://jobsearcher.com/jobs/a1029ca97361aef707dc10de"}}