Sr. Manufacturing Engineer

Job title : Sr. Manufacturing Engineer

Client : Medical Device Manufacturing company

Duration : 12 months with a possibility for extension

Location : San Diego, CA or Northridge, CA

Shift : 1st shift

Job Overview

• The Senior Manufacturing Engineer serves as the technical process owner responsible for manufacturing process validations, performance, equipment readiness, capacity expansion, and continuous improvement.
• The role focuses on achieving yield, capacity, throughput, reliability, and quality goals by driving the development, validation, implementation, and optimization of manufacturing processes.
• The Senior Manufacturing Engineer partners with internal and external stakeholders to support production objectives, resolve technical challenges, and execute strategic initiatives that improve manufacturing capability, efficiency, and reliability.

Key Responsibilities:

• Manufacturing Process Engineering
• Design manufacturing processes, procedures, and production layouts for semi-automated equipment installation, processing, and material handling.
  Adapt machine and equipment designs to factory and production conditions.
  Incorporate inspection and testing requirements into production plans.
  Develop and maintain manufacturing process specifications, work instructions, and engineering documentation.
  Provide engineering guidance on design concepts and specification requirements to optimize equipment and manufacturing techniques.
  Equipment & Process Validation:
• Develop and execute equipment and process validation activities.
  Create and execute:IQ – Installation Qualification,*OQ – Operational Qualification,*PQ – Performance Qualification
  Develop and validate test methods.
  Inspect machinery, equipment, and tools to verify efficiency and performance.
  Investigate equipment/process deficiencies and implement corrective actions.
  Automation & Advanced Manufacturing:
• Supported automation initiatives and advanced manufacturing technologies.
  Partnered with equipment suppliers and internal stakeholders to improve equipment capability and reliability.
  Supported equipment readiness and manufacturing scale-up.
  Quality & Problem Solving:
• Served as the primary technical escalation point for complex manufacturing and quality issues.
  Lead Root Cause Investigations using structured problem-solving methodologies, including: 5 Why,Fishbone Analysis ,Statistical Analysis
  Ensure manufacturing processes meet applicable quality and regulatory requirements.
  Continuous Improvement & Manufacturing Performance:
• Lead initiatives to: Improve yield, Reduce scrap, Increase throughput,*Optimize labor utilization,Improve manufacturing reliability,*Develop manufacturing strategies for commercial production ramp-up,Identify and eliminate production bottlenecks impacting manufacturing performance,Drive continuous improvement of manufacturing processes and equipment.
  Regulatory Compliance:
• Ensure manufacturing processes and procedures comply with: FDA Quality System Regulations (QSR),ISO 13485,Company procedures and quality requirements