R&D Change Management Specialist

Interview : VideoVisa : USC, GCDescription :Position OverviewThe Project Engineering Administrator, R&D is responsible for end-to-end ownership and execution of R&D change orders supporting new product development, launch readiness, and sustaining production. This role serves as the primary author, owner, and driver of Engineering Change Orders (ECOs, PCOs, and, as applicable, QCOs, DCOs, and TCOs) within Insulet's Product Lifecycle Management (PLM) system.This position partners closely with Engineering Project Managers (EPMs), R&D, Production, and cross-functional stakeholders to ensure change orders are authored accurately, routed efficiently, and driven through approval to completion. Success in this role is measured by predictable execution, strong cross-functional coordination, and the ability to drive complex changes to closure in alignment with project timelines, regulatory requirements, and manufacturing readiness.Key ResponsibilitiesChange Order Ownership & ExecutionServe as the primary owner and author of R&D change orders (ECOs, PCOs, and occasional QCOs, DCOs, and TCOs) from initiation through final approval and releaseAuthor, route, monitor, and actively drive change orders through approval, ensuring timely completion and resolution of delaysPartner with EPMs and change requestors to align change content, timing, and approvals with project milestones and production needsEnsure all change orders are properly structured, include required documentation, and comply with internal procedures and Quality System requirementsStakeholder Collaboration & Schedule SupportAct as a key coordination point across R&D, Document Control, Manufacturing, Quality, Regulatory, and Supply ChainProactively identify risks to change timelines and escalate or mitigate issues impacting launch or production schedulesTranslate technical inputs into compliant, well-structured PLM change recordsPLM Configuration & Documentation ManagementManage and maintain product structures within the PLM system, including Bills of Materials (BOMs), Device Master Records (DMRs), drawings, labeling specifications, and related configuration itemsSupport the generation, maintenance, and traceability of Design History File (DHF) documentation related to engineering changesServe as an R&D subject matter expert for PLM change management processes and best practicesCollaborate with Document Control to improve efficiency within PLM workflowsAdditional SupportSupport creation and approval of Part Approval Plans (PAPs) for new components and suppliersAssist R&D technicians with configuration control and documentation for development, verification, clinical, and pilot buildsPerform additional administrative and coordination duties related to R&D change management and product developmentQualificationsMinimum RequirementsAssociate's degree or equivalent experience in a technical or engineering-related field2+ years of experience working with PLM systems, including engineering change order management2+ years of experience in a cross-functional product development environmentStrong ability to manage work end-to-end, prioritize competing tasks, and meet deadlinesSolid understanding of Design Controls, configuration management, and product lifecycle management within a regulated Quality Management System (QMS)Proven ability to collaborate across engineering, quality, manufacturing, regulatory, and supply chain teamsPreferred QualificationsBachelor's degree in engineering or a related technical disciplineExperience in FDA-regulated medical device environments, including ISO 13485, ISO 14971, IEC 60601, and IEC 62304Experience supporting product launches and sustaining production through structured change management processesStrong organizational, communication, and stakeholder management skills