{"schemaVersion":"jobsearcher.job.v1","id":"c69d0c5ddd5fd2a3f4bda6bb","url":"https://jobsearcher.com/jobs/c69d0c5ddd5fd2a3f4bda6bb","canonicalUrl":"https://jobsearcher.com/jobs/c69d0c5ddd5fd2a3f4bda6bb","title":"Senior Component Engineer","description":"Description:\nCompany & Job Overview\nDiality is a medical device company focused on developing solutions to improve lives impacted by kidney disease. Diality offers the Moda-flx Hemodialysis System, a user-friendly, mobile, and connected hemodialysis system designed to maximize clinical flexibility and ease-of-use for both clinical and non-clinical users. The Moda-flx Hemodialysis system combines flow rate capabilities of conventional in-center dialysis devices with a fully integrated reverse osmosis (RO) water filtration system to provide a broad range of prescriptions and meet the needs of any professional dialysis care setting.\nWe are seeking a Sr. Component Engineer to lead component engineering activities across product development and manufacturing, with primary responsibility for component governance, risk mitigation, regulatory compliance, and supply continuity. This role partners closely with Engineering, Supply Chain, Quality, and Manufacturing to establish robust component strategies, manage component life-cycle risks, evaluate Product Change Notifications (PCNs), ensure RoHS/REACH compliance, qualify alternate and second-source components, and drive cost optimization initiatives. The position plays a critical role in maintaining a resilient component portfolio that supports uninterrupted manufacturing, regulatory requirements, and long-term product sustainability.\nResponsibilities\nComponent Selection & Design Support\nPartner with Engineering during product development to ensure component selections meet performance, cost, quality, and supply continuity objectives.\nReview new component introductions for technical suitability, approved sourcing, and long-term availability.\nSupport design reviews by identifying component-related risks and recommending mitigation strategies prior to design release.\nSupport Engineering Change Orders (ECOs) related to component additions, substitutions, and obsolescence.\nComponent Lifecycle & Risk Management\nMonitor component lifecycle status (Active, NRND, EOL) and proactively identify supply chain risks.\nDevelop and implement mitigation strategies, including alternate component qualification and second-source recommendations.\nEvaluate supplier changes, Product Change Notifications (PCNs), and End-of-Life (EOL) notices for business and technical impact.\nSupport long-term component strategies to minimize supply disruptions and sustain product availability.\nCompliance & Component Governance\nEnsure components comply with applicable regulatory and environmental requirements, including RoHS, REACH, and conflict minerals.\nMaintain approved component specifications, manufacturer information, and sourcing data within PLM and ERP systems.\nSupport component standardization initiatives to reduce complexity and improve reuse.\nMaintain component data integrity and support audit readiness.\nSupply Chain & Cost Optimization\nPartner with Supply Chain to identify long lead-time components and develop sourcing strategies to improve supply continuity.\nEngage suppliers to evaluate alternate manufacturers, cross-references, and equivalent components.\nSupport supplier qualification activities and technical evaluations of new component sources.\nIdentify opportunities for component cost reduction through standardization, alternate sourcing, and value engineering.\nCross-Functional Support\nServe as the primary technical interface between Engineering, Supply Chain, Quality, Manufacturing, and suppliers on component-related matters.\nSupport manufacturing and supplier teams in resolving component-related issues during DVT and production builds.\nParticipate in cross-functional risk assessments to improve component reliability, availability, and manufacturability.\nSupport continuous improvement initiatives related to component management and supply chain resilience.\nData & Documentation Management\nEnsure component documentation, compliance records, and technical specifications are complete prior to product release.\nSupport traceability, configuration management, and engineering change activities throughout the product lifecycle.\nRequirements:\nRequired Skills & Abilities\nWorking knowledge of environmental and regulatory compliance requirements, including RoHS, REACH, and Conflict Minerals.\nStrong analytical and problem-solving skills with the ability to assess technical and supply chain risks and recommend practical solutions.\nExcellent organizational, communication, and project coordination skills with the ability to manage multiple priorities in a fast-paced environment.\nSelf-motivated with the ability to work independently while effectively collaborating across cross-functional teams.\nEducation & Experience\nBachelor’s degree in Electrical, Mechanical, Industrial Engineering, or related technical field.\n5+ years of experience in component engineering, hardware engineering, or a related technical role.\nExperience supporting new product development through design, verification, design transfer and manufacturing release.\nStrong understanding of electronic, electromechanical, and mechanical components, including selection, qualification, and application.\nExperience managing components’ lifecycle, including Active, NRND, End-of-Life (EOL), Product Change Notifications (PCNs), and obsolescence mitigation.\nExperience evaluating supply chain risks and developing alternate sourcing and second-source strategies.\nExperience reviewing component datasheets and performing fit, form, and function evaluations for alternate components.\nExperience working with Product Lifecycle Management (PLM) and Enterprise Resource Planning (ERP) systems (Propel and NetSuite preferred).\nExperience supporting cross-functional teams including Engineering, Supply Chain, Manufacturing, Quality, and Supplier Quality.\nExperience in a regulated industry, preferably medical devices, with knowledge of ISO 13485 and FDA 21 CFR Part 820/QMS requirements.\nTravel\nn/a\nPhysical Requirements\nSitting at a desk utilizing a computer\nThe information contained in this job description is for compliance with the Americans with Disabilities Act (ADA) and is not an exhaustive list of duties performed for this position.","company":"Diality","rawCompany":"diality","city":"Irvine","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-08-05T10:39:10.381Z","occupations":[{"code":"17-2031.00","title":"Bioengineers and Biomedical Engineers","slug":"bioengineers-and-biomedical-engineers"},{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"}],"industries":[{"code":"334419","title":"Other Electronic Component Manufacturing","slug":"other-electronic-component-manufacturing"},{"code":"621492","title":"Kidney Dialysis Centers","slug":"kidney-dialysis-centers"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Senior Component Engineer","description":"Description:\nCompany & Job Overview\nDiality is a medical device company focused on developing solutions to improve lives impacted by kidney disease. Diality offers the Moda-flx Hemodialysis System, a user-friendly, mobile, and connected hemodialysis system designed to maximize clinical flexibility and ease-of-use for both clinical and non-clinical users. The Moda-flx Hemodialysis system combines flow rate capabilities of conventional in-center dialysis devices with a fully integrated reverse osmosis (RO) water filtration system to provide a broad range of prescriptions and meet the needs of any professional dialysis care setting.\nWe are seeking a Sr. Component Engineer to lead component engineering activities across product development and manufacturing, with primary responsibility for component governance, risk mitigation, regulatory compliance, and supply continuity. This role partners closely with Engineering, Supply Chain, Quality, and Manufacturing to establish robust component strategies, manage component life-cycle risks, evaluate Product Change Notifications (PCNs), ensure RoHS/REACH compliance, qualify alternate and second-source components, and drive cost optimization initiatives. The position plays a critical role in maintaining a resilient component portfolio that supports uninterrupted manufacturing, regulatory requirements, and long-term product sustainability.\nResponsibilities\nComponent Selection & Design Support\nPartner with Engineering during product development to ensure component selections meet performance, cost, quality, and supply continuity objectives.\nReview new component introductions for technical suitability, approved sourcing, and long-term availability.\nSupport design reviews by identifying component-related risks and recommending mitigation strategies prior to design release.\nSupport Engineering Change Orders (ECOs) related to component additions, substitutions, and obsolescence.\nComponent Lifecycle & Risk Management\nMonitor component lifecycle status (Active, NRND, EOL) and proactively identify supply chain risks.\nDevelop and implement mitigation strategies, including alternate component qualification and second-source recommendations.\nEvaluate supplier changes, Product Change Notifications (PCNs), and End-of-Life (EOL) notices for business and technical impact.\nSupport long-term component strategies to minimize supply disruptions and sustain product availability.\nCompliance & Component Governance\nEnsure components comply with applicable regulatory and environmental requirements, including RoHS, REACH, and conflict minerals.\nMaintain approved component specifications, manufacturer information, and sourcing data within PLM and ERP systems.\nSupport component standardization initiatives to reduce complexity and improve reuse.\nMaintain component data integrity and support audit readiness.\nSupply Chain & Cost Optimization\nPartner with Supply Chain to identify long lead-time components and develop sourcing strategies to improve supply continuity.\nEngage suppliers to evaluate alternate manufacturers, cross-references, and equivalent components.\nSupport supplier qualification activities and technical evaluations of new component sources.\nIdentify opportunities for component cost reduction through standardization, alternate sourcing, and value engineering.\nCross-Functional Support\nServe as the primary technical interface between Engineering, Supply Chain, Quality, Manufacturing, and suppliers on component-related matters.\nSupport manufacturing and supplier teams in resolving component-related issues during DVT and production builds.\nParticipate in cross-functional risk assessments to improve component reliability, availability, and manufacturability.\nSupport continuous improvement initiatives related to component management and supply chain resilience.\nData & Documentation Management\nEnsure component documentation, compliance records, and technical specifications are complete prior to product release.\nSupport traceability, configuration management, and engineering change activities throughout the product lifecycle.\nRequirements:\nRequired Skills & Abilities\nWorking knowledge of environmental and regulatory compliance requirements, including RoHS, REACH, and Conflict Minerals.\nStrong analytical and problem-solving skills with the ability to assess technical and supply chain risks and recommend practical solutions.\nExcellent organizational, communication, and project coordination skills with the ability to manage multiple priorities in a fast-paced environment.\nSelf-motivated with the ability to work independently while effectively collaborating across cross-functional teams.\nEducation & Experience\nBachelor’s degree in Electrical, Mechanical, Industrial Engineering, or related technical field.\n5+ years of experience in component engineering, hardware engineering, or a related technical role.\nExperience supporting new product development through design, verification, design transfer and manufacturing release.\nStrong understanding of electronic, electromechanical, and mechanical components, including selection, qualification, and application.\nExperience managing components’ lifecycle, including Active, NRND, End-of-Life (EOL), Product Change Notifications (PCNs), and obsolescence mitigation.\nExperience evaluating supply chain risks and developing alternate sourcing and second-source strategies.\nExperience reviewing component datasheets and performing fit, form, and function evaluations for alternate components.\nExperience working with Product Lifecycle Management (PLM) and Enterprise Resource Planning (ERP) systems (Propel and NetSuite preferred).\nExperience supporting cross-functional teams including Engineering, Supply Chain, Manufacturing, Quality, and Supplier Quality.\nExperience in a regulated industry, preferably medical devices, with knowledge of ISO 13485 and FDA 21 CFR Part 820/QMS requirements.\nTravel\nn/a\nPhysical Requirements\nSitting at a desk utilizing a computer\nThe information contained in this job description is for compliance with the Americans with Disabilities Act (ADA) and is not an exhaustive list of duties performed for this position.","datePosted":"2026-08-05T10:39:10.381Z","dateModified":"2026-08-05T10:39:10.381Z","hiringOrganization":{"@type":"Organization","name":"Diality","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Irvine","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"c69d0c5ddd5fd2a3f4bda6bb"},"url":"https://jobsearcher.com/jobs/c69d0c5ddd5fd2a3f4bda6bb"}}