Equipment Engineer

Equipment EngineerMechanical, Manufacturing, or Industrial Engineer with 5–10 years of experience in medical device equipment development and manufacturing. Expertise in assembly equipment development, process validation (IQ/OQ/PQ), DFM/DFA, MSA, Gage R&R, FMEA, and process characterization. Proven ability to develop robust manufacturing processes, manage equipment suppliers, support product commercialization, and drive continuous improvements in GMP, ISO 13485, and FDA-regulated environments. Strong cross-functional collaboration, technical problem-solving, and risk management skills.Roles & ResponsibilitiesFully understand the equipment development road map (TR011027).Understand equipment concept creation, review approval, build, run off, FAT, software validation, IQ, OQ, PQ road map requirements.Fully understand the equipment development procedure WE0179 and associated deliverables including ERR, ESRR, EFMEA, and WRAPS/Safety/Ergo assessments.Deliver robust assembly processes and associated equipment that achieve cycle time, cost, capacity, and quality requirements (MSA, GRR).Continue ownership and support of equipment beyond IQ/OQ/PQ qualification and throughout the stabilization period. This includes handling scrap and supply disruptions, equipment/process improvement projects, and overall stabilization of the process while ramping up production prior to LCE/Plant handoff.Knowledge of medical-specific assembly technologies, equipment supplier base, and supplier capabilities.Knowledge of equipment cost and lead time.Provide significant input to the capital budget estimate.Understand the connection between product requirements and each assembly station.Generate equipment requirements.Lead the DFA assessment for each assigned station and provide feedback to the design team.Provide oversight and leadership of the process characterization strategy for each assigned station.Deliver component, assembly, and supply chain strategy project deliverables at each phase of the project.Drive critical product requirements cascading to component and assembly processes.Transform design information, including component drawings and models, product requirements, AFMEA, and DFMEA, into a robust manufacturing process.Identify and escalate potential development-related risks and provide input to the project RISDA.Develop strategies to mitigate identified risks.Proactively develop strategies to rapidly react to design changes and provide flexibility through standardized/family tools, insert strategies, modularity, and similar approaches.Provide critical input to the development of project schedules, expense budgets, and capital budgets, including capital tooling and qualification costs and schedules.Assist the LDE and Project Director with identifying required development resources.Escalate needs appropriately to help prioritize development team tasks.Act as the liaison between the Design team and component/equipment suppliers.Provide the "voice of manufacturing" to influence design and include DFM/DFA feedback while maintaining Design Intent.Required SkillsEquipment DesignEquipment DevelopmentEquipment ManufacturingManufacturing AutomationEquipment CommissioningFactory Acceptance Testing (FAT)Assembly EquipmentManufacturing EquipmentProcess ValidationIQ/OQ/PQSoftware ValidationDFMDFAMSAGage R&R / GR&RFMEA / DFMEA / EFMEA / AFMEAProcess CharacterizationEquipment RequirementsMedical Device ManufacturingEquipment Supplier ManagementManufacturing Process DevelopmentRisk ManagementCapital EquipmentProduct CommercializationGMPISO 13485FDA-Regulated EnvironmentQualificationsB.E./B.Tech in Mechanical, Manufacturing, or Industrial Engineering.5–10 years of experience in medical device manufacturing and equipment development.Strong experience in equipment design, development, FAT, commissioning, and manufacturing automation.Experience with assembly equipment development and manufacturing processes.Experience with IQ/OQ/PQ, DFM/DFA, MSA, Gage R&R, FMEA, and process characterization.Medical domain experience is required.Strong cross-functional collaboration, technical problem-solving, supplier management, and risk management skills.