Manufacturing Engineer

Job Title: Manufacturing Engineer
Location: Camarillo, CA
Duration: 12 Months
Job Summary

Manufacturing Engineer with 6+ years of experience in medical device and life sciences manufacturing , specializing in NPI, process development, process optimization, equipment qualification, test method validation, and continuous improvement . Strong experience working within GMP, FDA, and ISO 13485 regulated environments, supporting products from development through production scale-up while improving yield, quality, throughput, and compliance.

Key Responsibilities

• Lead NPI, process development, process optimization, and manufacturing scale-up activities.
• Develop and execute DOE, statistical analysis, SPC, ANOVA, and control-chart studies using Minitab/JMP.
• Execute and document IQ/OQ/PQ equipment qualification and validation activities.
• Develop and validate functional and destructive Test Methods (TMV) using Attribute/Variable methods and Gage R&R .
• Prepare and maintain URS, IQ/OQ/PQ protocols, SOPs, MPIs, Engineering Reports, BOMs, Work Instructions, and validation documentation .
• Support Design for Manufacturability (DFM) and Design Verification & Validation (V&V) builds for new products.
• Develop tooling and fixtures using SolidWorks and apply GD&T principles to manufacturing designs.
• Conduct pFMEA, root-cause analysis, CAPA, yield analysis, cycle-time studies, and continuous improvement initiatives.
• Support sterilization validation , including EO and Gamma processes, in accordance with applicable standards.
• Partner with R&D, Quality, Supply Chain, Operations, and suppliers to resolve manufacturing and material issues.
• Support injection molding, silicone processing, thermoforming, packaging, serialization, and other medical-device manufacturing processes.
• Manage ECO/DCO process changes through QMS/PLM systems such as Arena.
• Support facility expansion, equipment installation, calibration, preventive maintenance, and qualification.
• Drive Lean/Six Sigma initiatives using DMAIC, 5S, A3, 8D, PDCA, Gemba, and Value Stream Mapping .

Required Skills

• 6+ years of Manufacturing/Process Engineering experience in medical device or life sciences.
• Strong NPI and process development experience.
• Hands-on IQ/OQ/PQ, TMV, Gage R&R, DOE, SPC, ANOVA, and pFMEA experience.
• Knowledge of GMP, FDA, ISO 13485, and regulated manufacturing environments .
• Experience with CAPA, RCA, continuous improvement, and process validation .
• Proficiency with Minitab/JMP, SolidWorks, SAP, MES, Arena, Windchill, and Microsoft Office .
• Strong knowledge of GD&T, tooling/fixture design, injection molding, and manufacturing processes .
• Experience with Lean Manufacturing/Six Sigma methodologies .
• Strong technical documentation, cross-functional collaboration, and project management skills.