Project Engineer

eWorking knowledge of use-related risk analysis, human factors, risk management, or product development preferre d5+ years of experience in pharmaceutical, medical device, combination product, or other regulated industry environments .Expertise in DHF management and creating various Design Control documents in compliance with applicable regulations .Strong organizational, facilitation, and communication skills .Familiarity with relevant human factors and risk management expectations .Primary Responsibility: Use-Related Risk Analysis (URRA )Lead planning and coordination of creating use-related risk analysis activities across all assigned programs .Facilitate cross-functional meetings to drive development of use-related risk analyses, ensuring team members provide timely inputs for which they are responsible .Partner with functional experts — including human factors, quality, clinical, medical safety, development, and manufacturing — to support accurate documentation of hazards, use scenarios, failure modes (i.e., use errors), risks, and mitigations .Monitor progress against milestones and proactively escal risks, delays, and unresolved issues to appropriate stakeholders .Support team development and review of URRA documentation to ensure delivery of inspection-ready records to the URRA owner .Drive consistency in URRA process execution and continuously identify opportunities for process improvement esIn support of the broader systems engineering framework, you will support the following activities and deliverable onUser and Stakeholder Needs Definiti onUse Case Analys isStandards Coverage Analys isProduct Requirements Definiti tyRisk Management planning and reporti entUse-Related Risk Assessments, Design FMEAs, and Process FM EAsChange Managem entOversight and integration of Third-Party Development activit iesIntegration of Design Control and Quality by Design (QbD) activit iesQualificat ionsDemonstrated ability to resolve key project hurdles and assumptions by effectively utilizing available information and technical expert ise.Expertise in end-to-end product development from initial concept through market release, with direct experience in combination product or medical device development; familiarity with FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO 14971, ISO 13485, and EU MDR prefer red.Expertise in Systems Engineering principles including user and stakeholder need definition, requirements definition, risk management, product architecture, configuration management, traceability, and change managem ent.Expertise in DHF management and creating various Design Control documents in compliance with applicable regulati ons.Working knowledge of use-related risk analysis, human factors, and risk management methodolog ies.Strong organizational, facilitation, and communication skills with the ability to influence across a matrixed organization and manage competing priorit ies.Strong analytical and decision-making skills; self-driven and proactive in appro ach.Experience creating and managing project schedules and identifying project risks and mitigation pl ans.Proficiency with project tracking and document management to ols.Experience interfacing with third-party vendors, including communication management, deliverable acceptance testing, and multi-cultural awaren essPreferred Exper ienceExperience supporting drug product and delivery system develop ment.Familiarity with relevant human factors and risk management regulatory expectat ions.Ability to synthesize complex technical input into clear, actionable plans and documenta tion.Demonstrated proactive, collaborative approach in a fast-paced, highly matrixed environ ment.Experience in vendor communication, management, and deliverable acceptance tes tingEducation & Expe rienceBS in Engineering, Science, or a closely related discipline with 10+ years of relevant experience; or MS with 8+ years of exper ience.5+ years of experience specifically in pharmaceutical, medical device, combination product, or other regulated industry environments pref erred.Demonstrated scientific writing skills and strong verbal communication s kills.Ability to multitask effectively and deliver results within established time #J-18808-Ljbffr