Immediate need for a talented Senior Manufacturing Engineer . This is a 12+months contract opportunity with long-term potential and is located in San Diego, CA(Onsite). Please review the job description below and contact me ASAP if you are interested.
Job ID:26-29668
Pay Range: $80 - $85/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
- Design manufacturing processes, procedures, and production layouts for semi-automation equipment installation, processing, and material handling.
- Adapt machine or equipment design to factory and production conditions, incorporating inspection and test requirements into the production plan.
- Inspect performance of machinery, equipment, and tools to verify efficiency, investigating and initiating corrective actions to ensure product quality.
- Develop and maintain manufacturing process specifications, work instructions, and engineering documentation.
- Provide guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
- Develop and execute equipment and process validation activities, including IQ, OQ, and PQ protocols and test method development and validation.
- Support automation initiatives and advanced manufacturing technologies.
- Serve as the primary technical escalation point for complex manufacturing and quality issues.
- Lead root cause investigations utilizing structured problem-solving tools such as 5 Why, Fishbone Analysis, and Statistical Analysis.
- Lead initiatives to improve yield, reduce scrap, increase throughput, and optimize labor utilization.
- Partner with equipment suppliers and internal stakeholders to improve equipment capability and reliability.
- Develop manufacturing strategies for commercial production ramp-up, identifying and eliminating bottlenecks impacting manufacturing performance.
- Ensure processes and procedures comply with FDA Quality System Regulations, ISO 13485 requirements, and company procedures.
Key Requirements and Technology Experience:
- Minimum of 4 years of relevant experience in manufacturing engineering, or an advanced degree with a minimum of 2 years relevant experience.
- Strong understanding of manufacturing process validation and equipment qualification.
- Experience supporting medical device manufacturing operations.
- Proficiency in statistical analysis and process control methodologies.
- Ability to travel up to 40%.
- Advanced knowledge of Microsoft Office, SAP, MES, AutoCAD, SolidWorks, Minitab, and Document Management Systems.
Our client is a leading Medical Equipment Manufacturing Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
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