Analyze and interpret PMS dataIdentify and elevate instances when products are not achieving the intended performance based upon anticipated levels of frequency and/or severityIdentify and evaluate new failure modes when encounteredMaintain procedures, as necessarySupport responding to requests for additional information from competent authorities, registries and notified bodyWorking cross-functionally with Quality, Regulatory, Clinical Affair and Operations departments to fulfill ad‑hoc data requests and deliver detailed analysis of PMS dataDevelop and maintain knowledge of support systems including MasterControl, JDE, Global Complaint System (GCS) and Power BI Tool KitPerforms other related duties and responsibilities as assignedAbility to travel up to 5% of the timeEducation And ExperienceRequires a minimum of a bachelor's degree, Engineering Degree, or degree in a technical fieldMinimum of four years' experience in engineering or quality engineering experience within the medical device, pharmaceutical, or equivalent industryKnowledge And SkillsRequired QualificationsMedical device experience working with Class I, II, and III devicesApply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)Ability to develop solutions with business impactWorking knowledge of statistical and risk assessment techniquesWorking knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologiesAbility to make and present risk-based decisionsStrong interpersonal skillsAbility to create and provide trainingProblem solving abilityAbility to create, review and coordinate test protocols and reportsAbility to generate engineering proposalsOral and written presentation skillsAbility to lead cross functional teamsAbility to provide analysis within strict timeline requirements and assuming accountability toward delivering on agreed upon commitmentsUnderstanding of regulatory requirements including ISO 13485, ISO 14971Proficient in Windows OS, Microsoft Office Suite particularly PowerPointProficient in Excel in manipulation of data using pivot tables, VLOOKUP, conditional formatting, formulas, and macrosPreferred QualificationsSQL database or equivalent data warehouse experience and associated validation activitiesAbility to develop & maintain dashboards using BI tools such as Power BI, QlikView, Tableau, Looker, Alteryx or equivalentPhysical DemandsWhile performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. Job ResponsibilitiesWork with a team to meet the requirements in generating periodic PMS related reportsIdentify development and training opportunities for PMS team along with ManagerParticipate in projects to align with BDX Quality, MDD/MDR strategies and regulatory submissionsIdentify gaps and maintain PMS processes in compliance with global regulationsParticipate in PMS planning and reportingExtract and generate PMS and operational performance data necessary for generating applicable reports.