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.