Staff Systems Engineer, Manufacturing
Title: Staff Systems Engineer, ManufacturingDescriptionLocation: OnsiteStatus Type: Full TimeQualificationsRequired:Bachelor’s Degree in technical discipline (e.g., Engineering or Science)Minimum of 8 years of experience supporting manufacturing operations in a regulated environmentDemonstrated experience with equipment development, quality systems, and manufacturing process controlsFamiliarity with SAP or similar enterprise manufacturing systemsExperience leading cross-functional initiatives or projectsStrong problem‑solving, root-cause analysis, and risk‑management skillsKnowledge of risk management tools such as PFMEA, control plans, and structured root cause analysisPreferred Experience with medical device manufacturing or other highly regulated industriesExperience with labeling/packaging systems (e.g., Bartender), packaging operations, and printer integrationFamiliarity with eDHR implementation or digital manufacturing systemsExperience with equipment procurement process (URS, FAT/SAT, characterization)Knowledge of PFMEA, control strategy development, or structured risk assessmentLean, Six Sigma, or similar continuous improvement training or certificationSkills & CompetenciesSystems thinker who connects equipment, process, software, documentation, and quality requirements into coherent frameworksOrganized and proactive; drives accountability across teamsStrong communication and technical writing skillsAbility to influence and build alignment cross-functionallyComfortable with ambiguity and able to create structure where none existsAble to manage and prioritize multiple initiativesAbility to develop and manage project timelines to drive completionPhysical RequirementsAbility to remain in a stationary position for extended periodsAbility to operate a computer and standard office equipmentResponsibilitiesRevamp and standardize process for equipment procurement and implementationCreate templates and guidance documents for equipment developmentCoach engineers on equipment documentationRefine Corrective Maintenance (CM) versus Change Control (CC) pathwaysEvaluate and recommend enhancements to engineering change categorizationServe as ME approver for CCs and provide coaching to engineers authoring change controlsServe as internal expert for SAP manufacturing processesRestart and maintain SAP equipment documentation effortSupport future digital initiatives including eDHR and facility expansionsOwn and maintain OPs, routers, and packaging and labeling processesPartner with PD labeling SMEs and IT to ensure compliant executionProvide ME input into site expansion strategy and third-party CMO integrationServe as project manager for ME deliverables associated with packaging initiativesLead PFMEA framework development and updatesEstablish equipment requirement specificationsAct as ME approver for DMRs and other documentationChampion simplification and standardizationLead cross-functional improvement initiativesSupport higher‑level systems such as SPC, line control, and traceabilityDevelop project schedules and define deliverablesNearest Major Market: Cincinnati