{"schemaVersion":"jobsearcher.job.v1","id":"dac71b0f5d7bb96952bc95a2","url":"https://jobsearcher.com/jobs/dac71b0f5d7bb96952bc95a2","canonicalUrl":"https://jobsearcher.com/jobs/dac71b0f5d7bb96952bc95a2","title":"Senior R&D Project Engineer","description":"Job Summary We are seeking a highly motivated Senior R&D Project Engineer to lead Cost Improvement Projects (CIP), design changes, supplier change initiatives, and product lifecycle management activities within a regulated medical device environment.\nThe ideal candidate will possess strong project management skills, medical device product development experience, regulatory knowledge, and the ability to collaborate effectively with cross‑functional teams and external suppliers.\nThis role will drive engineering projects from concept through implementation while ensuring compliance with quality and regulatory requirements.\nRoles & Responsibilities Lead Cost Improvement Projects (CIP) by coordinating activities across internal teams, suppliers, and stakeholders.\nDevelop project budgets by evaluating supplier quotations, feasibility studies, capital investments, validation activities, DVT samples, and bioburden requirements.\nCreate and manage project plans, schedules, timelines, and deliverables using Microsoft Project.\nLead design change, supplier change, and alternative sourcing projects to achieve cost savings and business objectives.\nPerform engineering testing, protocol development, test execution, and preparation of technical reports.\nConduct design reviews and collaborate with R&D, Quality, Regulatory Affairs, Manufacturing, and Supply Chain teams.\nDevelop and execute verification and validation activities in accordance with regulatory requirements.\nSupport process validation, risk assessments, and product change control activities.\nReview and finalize validation documentation, risk management files, and regulatory documentation.\nManage engineering change requests and supplier change requests through completion.\nProvide project updates, presentations, and recommendations to senior management.\nEnsure compliance with company quality systems, FDA regulations, and international medical device standards.\nDrive project execution while managing scope, risks, timelines, and budgets.\nEducation & Experience Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or related discipline.\nMinimum 6+ years of experience in Medical Device Product Development, R&D Engineering, Sustaining Engineering, or Project Engineering.\nExperience leading engineering projects in regulated medical device environments.\nStrong understanding of FDA regulations and medical device quality systems.\nExperience managing supplier change, design change, and cost improvement projects.\nExperience creating project plans and schedules using Microsoft Project.\nStrong communication, leadership, and stakeholder management skills.\nAbility to work independently and manage multiple projects simultaneously.\n\n#J-18808-Ljbffr","company":"Creative Solutions Services","rawCompany":"creative solutions services","city":"Irvine","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-06-17T04:16:57.935Z","occupations":[{"code":"11-9041.00","title":"Architectural and Engineering Managers","slug":"architectural-and-engineering-managers"},{"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":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Senior R&D Project Engineer","description":"Job Summary We are seeking a highly motivated Senior R&D Project Engineer to lead Cost Improvement Projects (CIP), design changes, supplier change initiatives, and product lifecycle management activities within a regulated medical device environment.\nThe ideal candidate will possess strong project management skills, medical device product development experience, regulatory knowledge, and the ability to collaborate effectively with cross‑functional teams and external suppliers.\nThis role will drive engineering projects from concept through implementation while ensuring compliance with quality and regulatory requirements.\nRoles & Responsibilities Lead Cost Improvement Projects (CIP) by coordinating activities across internal teams, suppliers, and stakeholders.\nDevelop project budgets by evaluating supplier quotations, feasibility studies, capital investments, validation activities, DVT samples, and bioburden requirements.\nCreate and manage project plans, schedules, timelines, and deliverables using Microsoft Project.\nLead design change, supplier change, and alternative sourcing projects to achieve cost savings and business objectives.\nPerform engineering testing, protocol development, test execution, and preparation of technical reports.\nConduct design reviews and collaborate with R&D, Quality, Regulatory Affairs, Manufacturing, and Supply Chain teams.\nDevelop and execute verification and validation activities in accordance with regulatory requirements.\nSupport process validation, risk assessments, and product change control activities.\nReview and finalize validation documentation, risk management files, and regulatory documentation.\nManage engineering change requests and supplier change requests through completion.\nProvide project updates, presentations, and recommendations to senior management.\nEnsure compliance with company quality systems, FDA regulations, and international medical device standards.\nDrive project execution while managing scope, risks, timelines, and budgets.\nEducation & Experience Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or related discipline.\nMinimum 6+ years of experience in Medical Device Product Development, R&D Engineering, Sustaining Engineering, or Project Engineering.\nExperience leading engineering projects in regulated medical device environments.\nStrong understanding of FDA regulations and medical device quality systems.\nExperience managing supplier change, design change, and cost improvement projects.\nExperience creating project plans and schedules using Microsoft Project.\nStrong communication, leadership, and stakeholder management skills.\nAbility to work independently and manage multiple projects simultaneously.\n\n#J-18808-Ljbffr","datePosted":"2026-06-17T04:16:57.935Z","dateModified":"2026-06-17T04:16:57.935Z","hiringOrganization":{"@type":"Organization","name":"Creative Solutions Services","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Irvine","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"dac71b0f5d7bb96952bc95a2"},"url":"https://jobsearcher.com/jobs/dac71b0f5d7bb96952bc95a2"}}