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 Do

• Design, develop, and validate manufacturing processes (IQ/OQ/PQ) for new and existing medical device product lines
• Develop and maintain process FMEAs, control plans, and work instructions
• Lead root cause analysis (RCA) and corrective/preventive action (CAPA) investigations for manufacturing nonconformances
• Apply Lean and Six Sigma methodologies to reduce defects, cycle time, and manufacturing costs
• Partner with R&D to ensure design-for-manufacturability (DFM) during new product development and Design Transfer activities
• Collaboration with Regulatory Affairs and Quality on technical files
• Define equipment specifications; lead procurement, installation, and commissioning of manufacturing equipment
• Maintain calibration and preventive maintenance programs for production equipment
• Ensure manufacturing documentation (DHR, DMR, batch records) is complete, accurate, and inspection-ready
• Support internal, customer, and regulatory audits (FDA, Notified Body); prepare responses to audit findings
• Maintain compliance with FDA, ISO 13485, and ISO 14971 requirements

What You Need

• Bachelor’s degree in Mechanical engineering, Biomedical Engineering, Industrial Engineering, or related discipline
• Minimum 5 years of engineering experience in a regulated medical device manufacturing environment
• Hands-on experience with process validation (IQ/OQ/PQ) and Design Transfer
• Working knowledge of ISO 13485 quality management systems
• Proficiency with statistical analysis and process capability tools (e.g., Cpk, Gage R&R)
• Experience authoring engineering documentation, including SOPs, work instructions, and validation protocols

Preferred

• Master’s degree in Engineering (Mechanical, Biomedical, Industrial, or related field)
• Six Sigma Green Belt or Black Belt certification
• Experience supporting Class II or Class III medical devices
• Familiarity with ISO 14971 risk management and FMEA methodologies
• Proficiency with CAD tools (e.g., SolidWorks) and ERP/MES systems
• Experience supporting FDA inspections or Notified Body audits
• Knowledge of sterilization methods (EtO, gamma, e-beam) or cleanroom manufacturing

United States of America Pay Ranges:

• US10 : $ 85,500.00 - 142,500.00 USD Annual

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