Senior Manufacturing Engineer

The Senior Manufacturing Engineer leads and coordinates the fabrication, installation, operation, maintenance, and repair of mechanical and electromechanical manufacturing systems. The position ensures quality and industry standards are consistently met or improved while driving efficiency, evaluating equipment performance and cost‑effectiveness, and recommending design or process modifications to enhance reliability and reduce malfunctions. This is an onsite role in Ventura, California.What You Will DoDesign, develop, and validate manufacturing processes (IQ/OQ/PQ) for new and existing medical device product linesDevelop and maintain process FMEAs, control plans, and work instructionsLead root cause analysis (RCA) and corrective/preventive action (CAPA) investigations for manufacturing nonconformancesApply Lean and Six Sigma methodologies to reduce defects, cycle time, and manufacturing costsPartner with R&D to ensure design‑for‑manufacturability (DFM) during new product development and Design Transfer activitiesCollaborate with Regulatory Affairs and Quality on technical filesDefine equipment specifications; lead procurement, installation, and commissioning of manufacturing equipmentMaintain calibration and preventive maintenance programs for production equipmentEnsure manufacturing documentation (DHR, DMR, batch records) is complete, accurate, and inspection‑readySupport internal, customer, and regulatory audits (FDA, Notified Body); prepare responses to audit findingsMaintain compliance with FDA, ISO 13485, and ISO 14971 requirementsWhat You NeedBachelor's degree in Mechanical engineering, Biomedical Engineering, Industrial Engineering, or related disciplineMinimum 5 years of engineering experience in a regulated medical device manufacturing environmentHands‑on experience with process validation (IQ/OQ/PQ) and Design TransferWorking knowledge of ISO 13485 quality management systemsProficiency with statistical analysis and process capability tools (e.g., Cpk, Gage R&R)Experience authoring engineering documentation, including SOPs, work instructions, and validation protocolsPreferredMaster's degree in Engineering (Mechanical, Biomedical, Industrial, or related field)Six Sigma Green Belt or Black Belt certificationExperience supporting ClassII or ClassIII medical devicesFamiliarity with ISO 14971 risk management and FMEA methodologiesProficiency with CAD tools (e.g., SolidWorks) and ERP/MES systemsExperience supporting FDA inspections or Notified Body auditsKnowledge of sterilization methods (EtO, gamma, e‑beam) or cleanroom manufacturingUnited States of America Pay RangesUS10: $101,000 - $168,400 USD Annual 85,500.00 - 114,000.00 - 142,500.00 USD AnnualHealth and Financial BenefitsHealth benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.#J-18808-Ljbffr