{"schemaVersion":"jobsearcher.job.v1","id":"bcb90437e708e70ab2ea5e87","url":"https://jobsearcher.com/jobs/bcb90437e708e70ab2ea5e87","canonicalUrl":"https://jobsearcher.com/jobs/bcb90437e708e70ab2ea5e87","title":"Senior Design Controls Engineer","description":"No C2C please!!!!!!!! No C2C please!!!!!!!!No C2C please!!!!!!!!No C2C please!!!!!!!!\nSenior Design Controls Engineer – Combination Products\nWe are looking a Senior Design Controls Engineer with 10 years of experience in the development of combination products, including injectables, prefilled syringes, auto-injectors, inhalation devices, and implantable drug-delivery systems. The successful candidate will lead the application of design controls, requirements engineering, risk management, traceability, verification and validation (V&V), and Quality by Design (QbD) principles, ensuring full regulatory compliance and design robustness.\nThis position plays a key role in product development and regulatory readiness by building and maintaining a robust Design History File (DHF) and integrating best practices aligned with FDA, ISO, and ICH standards.\nKey Responsibilities:\nDesign Controls & DHF (21 CFR 820.30 / ISO 13485)\nLead the structured implementation of design controls from concept through design transfer, in alignment with FDA 21 CFR 820.30 and ISO 13485.\nMaintain and oversee the Design History File (DHF) for a variety of combination product platforms including:\nInjectables and prefilled syringes\nAuto-injectors\nDry powder and metered dose inhalers\nImplantable drug-delivery systems\nOn-body delivery systems and wearable injectors\nEnsure DHF documentation is audit-ready and supports all regulatory submissions.\nRequirements Engineering & Traceability\nDefine and manage user needs, design inputs, system/subsystem requirements, and design outputs using structured methodologies.\nEnsure complete bi-directional traceability from user needs to risk mitigations, test protocols, and design verification results.\nFacilitate design input refinement, decomposition, and stakeholder alignment across functional teams.\nVerification & Validation (V&V)\nDevelop and lead verification and validation strategies tailored to complex combination products, ensuring design outputs meet design inputs and user needs.\nCollaborate with device engineering, human factors, analytical development, and clinical teams to ensure testing is robust and regulatory-compliant.\nEnsure V&V aligns with applicable standards:\nISO 11608 (needle-based injection systems)\nIEC 62366 (human factors/usability)\nFDA guidance for combination products and human factors engineering\nRisk Management (ISO 14971)\nLead risk management activities including hazard analysis, design and process FMEA, use-related risk analysis (URRA), and fault tree analysis (FTA).\nIntegrate risk controls into requirements and verification strategy.\nEnsure risk management files are current and fully aligned with product design evolution and lifecycle changes.\nQuality by Design (QbD – ICH Q8–Q10)\nApply QbD principles in the development of combination products with integrated drug and device components.\nIdentify and manage Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), and design space through collaboration with pharmaceutical development and manufacturing teams.\nParticipate in design of experiments (DOE) and control strategy development to ensure robust product performance.\nRegulatory Compliance\nEnsure compliance with combination product regulatory requirements, including:\n21 CFR Part 4 (cGMP for Combination Products)\n21 CFR 820, 210, 211\nEU MDR, ISO 13485, ISO 14971\nFDA guidance on Human Factors, Postmarket Surveillance, and Part 11\nProvide design documentation and support for regulatory filings: IND, NDA, ANDA, 510(k), PMA, and Technical Files for global markets.\nCross-functional Leadership & Mentorship\nCollaborate with R&D, Quality, Regulatory, Manufacturing, and Clinical teams to integrate design control requirements.\nAct as SME during internal and external audits.\nProvide guidance and mentorship to junior engineers and cross-functional teams on best practices in design assurance and documentation.\nEducation:\nBachelor’s degree in Mechanical Engineering, Biomedical Engineering, Systems Engineering, Chemical Engineering, or a related field.\nMaster’s degree preferred.\nExperience:\n10 years of experience in design assurance, product development, or quality engineering with combination products.\nProven experience working with at least two of the following platforms: injectables, inhalers, prefilled syringes, wearable injectors, or implantable systems.\nTechnical Skills:\nStrong expertise in:\nFDA 21 CFR 820.30, 21 CFR Part 4, ISO 13485, ISO 14971\nICH Q8–Q10 and applicable EU MDR expectations\nV&V planning and execution, risk analysis tools, usability engineering\nExperience with traceability and requirements management tools (e.g., Jama, DOORS, MatrixALM).\nProficiency in documentation platforms such as Veeva, MasterControl, Greenlight Guru.\nJob Type: Contract\nPay: $60.00 per hour\nExpected hours: 40 per week\nWork Location: Remote","company":"Systemsally","rawCompany":"systemsally","city":"Remote","state":"OR","isRemote":false,"isActive":false,"createdAt":"2026-08-09T14:06:06.721Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"11-9199.01","title":"Regulatory Affairs Managers","slug":"regulatory-affairs-managers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-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":"Senior Design Controls Engineer","description":"No C2C please!!!!!!!! No C2C please!!!!!!!!No C2C please!!!!!!!!No C2C please!!!!!!!!\nSenior Design Controls Engineer – Combination Products\nWe are looking a Senior Design Controls Engineer with 10 years of experience in the development of combination products, including injectables, prefilled syringes, auto-injectors, inhalation devices, and implantable drug-delivery systems. The successful candidate will lead the application of design controls, requirements engineering, risk management, traceability, verification and validation (V&V), and Quality by Design (QbD) principles, ensuring full regulatory compliance and design robustness.\nThis position plays a key role in product development and regulatory readiness by building and maintaining a robust Design History File (DHF) and integrating best practices aligned with FDA, ISO, and ICH standards.\nKey Responsibilities:\nDesign Controls & DHF (21 CFR 820.30 / ISO 13485)\nLead the structured implementation of design controls from concept through design transfer, in alignment with FDA 21 CFR 820.30 and ISO 13485.\nMaintain and oversee the Design History File (DHF) for a variety of combination product platforms including:\nInjectables and prefilled syringes\nAuto-injectors\nDry powder and metered dose inhalers\nImplantable drug-delivery systems\nOn-body delivery systems and wearable injectors\nEnsure DHF documentation is audit-ready and supports all regulatory submissions.\nRequirements Engineering & Traceability\nDefine and manage user needs, design inputs, system/subsystem requirements, and design outputs using structured methodologies.\nEnsure complete bi-directional traceability from user needs to risk mitigations, test protocols, and design verification results.\nFacilitate design input refinement, decomposition, and stakeholder alignment across functional teams.\nVerification & Validation (V&V)\nDevelop and lead verification and validation strategies tailored to complex combination products, ensuring design outputs meet design inputs and user needs.\nCollaborate with device engineering, human factors, analytical development, and clinical teams to ensure testing is robust and regulatory-compliant.\nEnsure V&V aligns with applicable standards:\nISO 11608 (needle-based injection systems)\nIEC 62366 (human factors/usability)\nFDA guidance for combination products and human factors engineering\nRisk Management (ISO 14971)\nLead risk management activities including hazard analysis, design and process FMEA, use-related risk analysis (URRA), and fault tree analysis (FTA).\nIntegrate risk controls into requirements and verification strategy.\nEnsure risk management files are current and fully aligned with product design evolution and lifecycle changes.\nQuality by Design (QbD – ICH Q8–Q10)\nApply QbD principles in the development of combination products with integrated drug and device components.\nIdentify and manage Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), and design space through collaboration with pharmaceutical development and manufacturing teams.\nParticipate in design of experiments (DOE) and control strategy development to ensure robust product performance.\nRegulatory Compliance\nEnsure compliance with combination product regulatory requirements, including:\n21 CFR Part 4 (cGMP for Combination Products)\n21 CFR 820, 210, 211\nEU MDR, ISO 13485, ISO 14971\nFDA guidance on Human Factors, Postmarket Surveillance, and Part 11\nProvide design documentation and support for regulatory filings: IND, NDA, ANDA, 510(k), PMA, and Technical Files for global markets.\nCross-functional Leadership & Mentorship\nCollaborate with R&D, Quality, Regulatory, Manufacturing, and Clinical teams to integrate design control requirements.\nAct as SME during internal and external audits.\nProvide guidance and mentorship to junior engineers and cross-functional teams on best practices in design assurance and documentation.\nEducation:\nBachelor’s degree in Mechanical Engineering, Biomedical Engineering, Systems Engineering, Chemical Engineering, or a related field.\nMaster’s degree preferred.\nExperience:\n10 years of experience in design assurance, product development, or quality engineering with combination products.\nProven experience working with at least two of the following platforms: injectables, inhalers, prefilled syringes, wearable injectors, or implantable systems.\nTechnical Skills:\nStrong expertise in:\nFDA 21 CFR 820.30, 21 CFR Part 4, ISO 13485, ISO 14971\nICH Q8–Q10 and applicable EU MDR expectations\nV&V planning and execution, risk analysis tools, usability engineering\nExperience with traceability and requirements management tools (e.g., Jama, DOORS, MatrixALM).\nProficiency in documentation platforms such as Veeva, MasterControl, Greenlight Guru.\nJob Type: Contract\nPay: $60.00 per hour\nExpected hours: 40 per week\nWork Location: Remote","datePosted":"2026-08-09T14:06:06.721Z","dateModified":"2026-08-09T14:06:06.721Z","hiringOrganization":{"@type":"Organization","name":"Systemsally","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Remote","addressRegion":"OR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"bcb90437e708e70ab2ea5e87"},"url":"https://jobsearcher.com/jobs/bcb90437e708e70ab2ea5e87"}}