Manufacturing Engineer II

Title: Manufacturing Engineer IILocation: Irvine, CADuration: 12 MonthsShift : 12 PM TO 8:30PM100% OnsiteSummaryWe are hiring a Manufacturing Engineer with 2–4 years of experience in a regulated (medical device/pharma) environment. The role involves supporting daily production, improving manufacturing processes, performing root cause analysis, and ensuring compliance with GMP/FDA standards. Candidates should have experience with process validation (IQ/OQ/PQ), statistical tools (SPC/DOE), and equipment/line support. Strong problem-solving skills and the ability to work independently in a fast-paced manufacturing setting are essential.ResponsibilitiesSupport daily manufacturing operationsImprove processes and resolve production issuesPerform root cause analysis and implement corrective actionsMonitor KPIs and drive continuous improvementLead equipment validation and lifecycle managementEnsure compliance with GMP, GDP, FDA, and ISO standardsMaintain manufacturing documentation and systemsQualificationsBachelor’s degree in Engineering2–4 years relevant experience (medical device preferred)Required SkillsStrong problem-solving (DMAIC, Root Cause Analysis)Statistical tools (DOE, SPC, basic data analysis)Knowledge of GMP, FDA, and ISO regulationsEquipment validation (IQ/OQ/PQ) and process validationSAP (BOMs, routers) or similar ERP systemsProcess improvement and lean manufacturing conceptsGood communication and cross-functional collaborationProficiency in MS Office (Excel, Word, PowerPoint)Consultants Eligible Benefits Upon Waiting PeriodMedical and Prescription Drug PlansDental PlanVision PlanHealth Savings Account (for High-Deductible Health Plans)Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)Supplemental Life InsuranceShort Term Disability (coverage varies by state)Long Term DisabilityCritical Illness, Hospital coverage, Accident InsuranceMetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance401(k)Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.