{"schemaVersion":"jobsearcher.job.v1","id":"d7b81c08b6500b3bee8e9a2d","url":"https://jobsearcher.com/jobs/d7b81c08b6500b3bee8e9a2d","canonicalUrl":"https://jobsearcher.com/jobs/d7b81c08b6500b3bee8e9a2d","title":"Sr. Mechanical Engineer","description":"Title: Sr. Mechanical Engineer\nLocation: Pleasanton, CA\nDuration: 7 Months\n100% Onsite\nSummary:\nProvides technical leadership in sustaining products for design, verification, investigation, reliability improvement of complex Class II and Class III medical devices, including Ventricular Assist Devices (VADs), extracorporeal blood pumps, oxygenators, and associated electromechanical systems.\n\nThis individual serves as a subject matter expert responsible for leading complex technical investigations, driving product improvements, influencing engineering strategy, and solving challenging system-level problems throughout the product lifecycle. The role requires extensive collaboration across R&D, Quality, Regulatory, Manufacturing, Operations, and Supplier teams to ensure product safety, reliability, compliance, and performance.\n\nResponsibilities:\n\nProvide technical leadership across multiple sustaining engineering initiatives involving Class II and Class III medical devices.\n\nLead complex technical investigations associated with product performance, complaints, CAPAs, nonconformances, and field issues using structured root cause analysis methodologies.\n\nResearch, develop, test, and sustain mechanical and electromechanical systems used in ventricular assist devices, extracorporeal blood pumps, oxygenators, and related cardiovascular products.\n\nDrive cross-functional efforts to identify, assess, and implement product, process, and reliability improvements throughout the product lifecycle\n\nApply experimental, analytical, empirical, and numerical methods to evaluate product performance, investigate failures, and support engineering decisions.\n\nDevelop test strategies, test methods, and protocols to evaluate system, subsystem, and component performance against product requirements.\n\nDesign, develop, qualify, and validate equipment and fixtures used for engineering verification, reliability testing, and failure analysis activities.\n\nIdentify technical risks and drive mitigation strategies throughout product development and sustaining activities.\n\nAnalyze complaint, post-market surveillance, manufacturing, and reliability data to identify trends and drive continuous improvement initiatives.\n\nCreate and review engineering drawings and specifications to ensure appropriate dimensioning, tolerancing, manufacturability, and assembly requirements.\n\nPerform and review tolerance analyses and engineering stack-ups to assess product robustness and manufacturability.\n\nProvide expertise in GD&T and mechanical system design principles.\n\nSupport design reviews and provide technical guidance to engineers across multiple disciplines.\n\nMentor and develop engineers through technical coaching, design reviews, and problem-solving activities.\n\nEvaluate manufacturing processes including precision machining, injection molding, silicone molding, extrusion, laser welding, ultrasonic welding, bonding, and mechanical assembly methods.\n\nSupport supplier selection, qualification, and technical evaluations, including assessments of manufacturing capability, capacity, process controls, and quality systems.\n\nCollaborate with regulatory, quality, and clinical teams to support submissions, audits, inspections, and responses to regulatory inquiries.\n\nEnsure compliance with FDA regulations, international standards, company procedures, Quality Management System requirements, and applicable regulatory requirements.\n\nSupport company initiatives as directed by management and contribute to continuous improvement of engineering processes, product quality, and operational excellence.\n\nMinimum Qualifications:\n\nBachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or related engineering discipline.\n\n15+ years of progressively increasing engineering responsibility supporting Class II and/or Class III medical devices, including product development, sustaining engineering, verification and validation, manufacturing support, and risk management activities.\n\nDemonstrated technical leadership of complex cross-functional programs and ability to influence technical decisions without direct authority.\n\nStrong understanding of FDA Design Controls, 21 CFR Part 820, product lifecycle management, and medical device development processes.\n\nExperience leading complex technical investigations and root cause analyses.\n\nExpertise in mechanical design, tolerance analysis, GD&T, materials, manufacturing processes, and assembly methods.\n\nExperience with risk management principles and methodologies, including FMEA analysis.\n\nStrong written, verbal, presentation, and technical communication skills.\n\nAbility to effectively communicate with engineers, management, auditors, regulators, suppliers, and customers.\n\nAbility to travel approximately 10%, including domestic and occasional international travel.\n\nPreferred Qualifications:\n\nMaster's degree in Mechanical Engineering, Biomedical Engineering, or related discipline\n\nExperience with ventricular assist devices (VADs), extracorporeal blood pumps, oxygenators, cardiovascular implants, or other implantable Class III medical devices.\n\nExperience supporting post-market surveillance activities, complaint investigations, CAPAs, and product reliability initiatives.\n\nExperience with reliability engineering, accelerated life testing, fatigue analysis, and statistical data analysis.\n\nExperience with medium- to high-volume medical device manufacturing environments.\n\nExperience with CAD systems, Design of Experiments (DOE), SPC, Six Sigma, and project management methodologies.\n\nKnowledge of ISO 13485, ISO 14971, EU MDR, and other applicable medical device standards and regulations.\n\nExperience working with external manufacturing partners and global suppliers.\n\nExposure to multidisciplinary engineering fields including electrical systems, software-controlled devices, polymers, biomaterials, and biological systems.\n\nPossibility to extend and/or convert but no guarantees.\n\nConsultants Eligible Benefits Upon Waiting Period:\n\nMedical and Prescription Drug Plans\n\nDental Plan\n\nVision Plan\n\nHealth Savings Account (for High-Deductible Health Plans)\n\nFlexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)\n\nSupplemental Life Insurance\n\nShort Term Disability (coverage varies by state)\n\nLong Term Disability\n\nCritical Illness, Hospital coverage, Accident Insurance\n\nMetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance\n\n401(k)\n\nAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.\n\nWorking together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.\n\n#J-18808-Ljbffr","company":"Abbott","rawCompany":"abbott","city":"Pleasanton","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-09-09T04:00:58.886Z","occupations":[{"code":"17-2141.00","title":"Mechanical Engineers","slug":"mechanical-engineers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"},{"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":"Sr. Mechanical Engineer","description":"Title: Sr. Mechanical Engineer\nLocation: Pleasanton, CA\nDuration: 7 Months\n100% Onsite\nSummary:\nProvides technical leadership in sustaining products for design, verification, investigation, reliability improvement of complex Class II and Class III medical devices, including Ventricular Assist Devices (VADs), extracorporeal blood pumps, oxygenators, and associated electromechanical systems.\n\nThis individual serves as a subject matter expert responsible for leading complex technical investigations, driving product improvements, influencing engineering strategy, and solving challenging system-level problems throughout the product lifecycle. The role requires extensive collaboration across R&D, Quality, Regulatory, Manufacturing, Operations, and Supplier teams to ensure product safety, reliability, compliance, and performance.\n\nResponsibilities:\n\nProvide technical leadership across multiple sustaining engineering initiatives involving Class II and Class III medical devices.\n\nLead complex technical investigations associated with product performance, complaints, CAPAs, nonconformances, and field issues using structured root cause analysis methodologies.\n\nResearch, develop, test, and sustain mechanical and electromechanical systems used in ventricular assist devices, extracorporeal blood pumps, oxygenators, and related cardiovascular products.\n\nDrive cross-functional efforts to identify, assess, and implement product, process, and reliability improvements throughout the product lifecycle\n\nApply experimental, analytical, empirical, and numerical methods to evaluate product performance, investigate failures, and support engineering decisions.\n\nDevelop test strategies, test methods, and protocols to evaluate system, subsystem, and component performance against product requirements.\n\nDesign, develop, qualify, and validate equipment and fixtures used for engineering verification, reliability testing, and failure analysis activities.\n\nIdentify technical risks and drive mitigation strategies throughout product development and sustaining activities.\n\nAnalyze complaint, post-market surveillance, manufacturing, and reliability data to identify trends and drive continuous improvement initiatives.\n\nCreate and review engineering drawings and specifications to ensure appropriate dimensioning, tolerancing, manufacturability, and assembly requirements.\n\nPerform and review tolerance analyses and engineering stack-ups to assess product robustness and manufacturability.\n\nProvide expertise in GD&T and mechanical system design principles.\n\nSupport design reviews and provide technical guidance to engineers across multiple disciplines.\n\nMentor and develop engineers through technical coaching, design reviews, and problem-solving activities.\n\nEvaluate manufacturing processes including precision machining, injection molding, silicone molding, extrusion, laser welding, ultrasonic welding, bonding, and mechanical assembly methods.\n\nSupport supplier selection, qualification, and technical evaluations, including assessments of manufacturing capability, capacity, process controls, and quality systems.\n\nCollaborate with regulatory, quality, and clinical teams to support submissions, audits, inspections, and responses to regulatory inquiries.\n\nEnsure compliance with FDA regulations, international standards, company procedures, Quality Management System requirements, and applicable regulatory requirements.\n\nSupport company initiatives as directed by management and contribute to continuous improvement of engineering processes, product quality, and operational excellence.\n\nMinimum Qualifications:\n\nBachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or related engineering discipline.\n\n15+ years of progressively increasing engineering responsibility supporting Class II and/or Class III medical devices, including product development, sustaining engineering, verification and validation, manufacturing support, and risk management activities.\n\nDemonstrated technical leadership of complex cross-functional programs and ability to influence technical decisions without direct authority.\n\nStrong understanding of FDA Design Controls, 21 CFR Part 820, product lifecycle management, and medical device development processes.\n\nExperience leading complex technical investigations and root cause analyses.\n\nExpertise in mechanical design, tolerance analysis, GD&T, materials, manufacturing processes, and assembly methods.\n\nExperience with risk management principles and methodologies, including FMEA analysis.\n\nStrong written, verbal, presentation, and technical communication skills.\n\nAbility to effectively communicate with engineers, management, auditors, regulators, suppliers, and customers.\n\nAbility to travel approximately 10%, including domestic and occasional international travel.\n\nPreferred Qualifications:\n\nMaster's degree in Mechanical Engineering, Biomedical Engineering, or related discipline\n\nExperience with ventricular assist devices (VADs), extracorporeal blood pumps, oxygenators, cardiovascular implants, or other implantable Class III medical devices.\n\nExperience supporting post-market surveillance activities, complaint investigations, CAPAs, and product reliability initiatives.\n\nExperience with reliability engineering, accelerated life testing, fatigue analysis, and statistical data analysis.\n\nExperience with medium- to high-volume medical device manufacturing environments.\n\nExperience with CAD systems, Design of Experiments (DOE), SPC, Six Sigma, and project management methodologies.\n\nKnowledge of ISO 13485, ISO 14971, EU MDR, and other applicable medical device standards and regulations.\n\nExperience working with external manufacturing partners and global suppliers.\n\nExposure to multidisciplinary engineering fields including electrical systems, software-controlled devices, polymers, biomaterials, and biological systems.\n\nPossibility to extend and/or convert but no guarantees.\n\nConsultants Eligible Benefits Upon Waiting Period:\n\nMedical and Prescription Drug Plans\n\nDental Plan\n\nVision Plan\n\nHealth Savings Account (for High-Deductible Health Plans)\n\nFlexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)\n\nSupplemental Life Insurance\n\nShort Term Disability (coverage varies by state)\n\nLong Term Disability\n\nCritical Illness, Hospital coverage, Accident Insurance\n\nMetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance\n\n401(k)\n\nAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.\n\nWorking together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.\n\n#J-18808-Ljbffr","datePosted":"2026-09-09T04:00:58.886Z","dateModified":"2026-09-09T04:00:58.886Z","hiringOrganization":{"@type":"Organization","name":"Abbott","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Pleasanton","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"d7b81c08b6500b3bee8e9a2d"},"url":"https://jobsearcher.com/jobs/d7b81c08b6500b3bee8e9a2d"}}