Project Manager

About VERO BiotechOur Mission: At VERO Biotech, our mission is to improve the lives of patients by developing innovative technologies that support critical care and respiratory therapy through inhaled nitric oxide delivery in the acute care hospital setting or wherever nitric oxide treatment is needed.We strive to exceed customer expectations in terms of safety, efficacy, and value by focusing on the science, development, and commercialization of our innovations.Position SummaryThe role is a highly organized, execution-oriented Project Manager to support critical business initiatives, including New Product Development (NPD), Business infrastructure, manufacturing and Quality programs.This role requires foundational experience in medical device development and is ideal for project managers that thrive in a fast-paced, cross-functional environment. The successful candidate will support planning, coordination, and documentation activities across R&D, Regulatory, Quality, Operations, and Commercial teams.This individual will play a critical role in ensuring timelines, deliverables, and design control requirements are met while building strong cross-functional alignment.Essential Duties and ResponsibilitiesProgram Execution and Coordination:Support of multiple concurrent, critical programs across various phasesMaintain detailed project plans, Gantt charts, and milestone tracking toolsTrack risks, action items, and dependencies across cross-functional teamsPrepare and distribute program dashboards and executive level updatesStrong communication skills and positive influence on the team quality and executionDesign Control and Regulatory SupportSupport adherence to FDA design control and change control requirementsAssist with maintenance of Design History FilesCoordinate inputs for regulatory submissionsTrack testing progress for V&V, human factors and usability testing, biocompatibility, etc.Support traceability matrix updates and requirement trackingCross-Functional AlignmentCoordinate across Engineering (hardware, software, systems), Clinical, Regulatory Affairs, Quality, Operations / Manufacturing, Supply Chain, Finance, and CommercialEscalate timeline risk and resource constraints earlyHelp ensure proper stakeholders are integrated into product development planningDocumentation and ProcessMaintain program documentation repositoriesAssist in preparing leadership summaries and board level materialsDrive continuous improvement in program managementCollect data and provide routine reporting on operational metrics and key performance indicators.Serves as a promoter of the program management processes and initiatives and assists company resources in the practice of these initiatives.Other duties as assigned by the manager.Bachelor’s degree in Engineering, Life Sciences, or related technical field2-5 years of experience in Medical Device development and technical project coordinationBasic understanding of FDA Design Controls, Verification and Validation processes, Change Control, and Risk ManagementExcellent written and oral communication skills.Strong organizational and problem-solving skills.Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.Acute attention to detailProven ability to handle multiple projects and meet deadlines.Strong knowledge of Microsoft Office (Excel, PowerPoint, etc.) as well as Project Management applicationsAbility to travel up to 25%Desired QualificationsExperience with agile and waterfall delivery environments.Experience supporting regulatory submission in combination products or respiratory/critical care devices.proven ability to work cross-functionally and act as a liaison between technical and business focused teamsPMP certificationCompetenciesExecution discipline and follow-throughSystems thinking and prioritizationClear communication and escalationCross-functional collaborationData-driven decision supportAccountability and ownershipComfortable in a fast-paced environment handling multiple tasks and projectsAble to organize and manage large amounts of files, tasks, schedules, and informationSelf-directed and able to work without supervisionEnergetic and eager to tackle new projects and ideasMust be a team playerComfortable interacting with individuals at all levels of the organization and across multiple sitesPhysical Demands and Work EnvironmentStandard office and laboratory environmentPeriodic hands-on engagement in lab or manufacturing settingsOccasional travel for customer visits, testing, supplier engagement, or regulatory meetingsThe above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. #J-18808-Ljbffr