Senior Manufacturing Engineer

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: $79 - $80/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:

• Designs manufacturing processes, procedures and production layouts for semi automation equipment installation, processing and material handling.
• Adapts machine or equipment design to factory and production conditions, incorporate inspection and test requirements into the production plan.
• Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• Develops and maintains manufacturing process specifications, work instructions, and engineering documentation
• Provides 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
• Supports 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, identify and eliminate bottlenecks impacting manufacturing performance.
• Ensures processes and procedures are in compliance with FDA Quality System Regulations, ISO 13485 requirements, and company procedures

Key Requirements and Technology Experience:

• Must have skills: Manufacturing Engineering, ISO 13485, Equipment Qualification
• Advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
• May have practical knowledge of project management.
• Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
• Experience supporting medical device manufacturing operations.
• Strong understanding of manufacturing process validation and equipment qualification. Experience with statistical analysis and process control methodologies.
• Able to travel ~50%

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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