Senior Manufacturing Engineer - Manufacturing Line / NPI

Job Description

Immediate need for a talented Senior Manufacturing Engineer – Manufacturing Line / NPI . 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.

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Job ID:26-29669

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Pay Range: $100 - $103/hour. Traveler benefits as per agency package. (Benefits vary by vendor and assignment.)

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Key Responsibilities:

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• Provide technical leadership and engineering ownership for manufacturing and production lines.
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• Support manufacturing line launch, NPI, production ramp-up, and hypercare activities.
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• Develop, optimize, and improve manufacturing processes, production layouts, equipment, tooling, and assembly operations.
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• Lead process validation and equipment qualification activities.
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• Support installation, integration, commissioning, and optimization of manufacturing equipment.
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• Troubleshoot and improve semi-automated manufacturing equipment, PLC-controlled systems, machine interfaces, and vision inspection systems.
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• Analyze production performance using OEE, yield, throughput, capacity, scrap, and efficiency metrics.
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• Identify opportunities to improve manufacturing capacity, quality, yield, and overall equipment effectiveness.
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• Apply SPC, statistical analysis, root cause analysis, and continuous improvement methodologies to manufacturing problems.
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• Lead technical investigations and corrective actions related to equipment, process, and quality issues.
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• Support manufacturing changes through appropriate change-control and engineering documentation processes.
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• Partner with Quality to ensure compliance with applicable FDA Quality System Regulations and ISO 13485 requirements.
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• Support manufacturing scale-up, technology transfer, process development, and product launches.
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• Provide technical leadership for capital equipment, automation, and manufacturing technology projects.
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• Evaluate manufacturing equipment, tools, processes, and technologies for performance, reliability, and scalability.
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• Develop manufacturing procedures, process documentation, validation documentation, and technical reports.
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• Collaborate with Operations, Quality, R&D, Supply Chain, and other stakeholders to resolve manufacturing challenges.
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• Mentor and provide technical guidance to Manufacturing Engineers and Process Engineers.
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Key Requirements and Technology Experience:

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• Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, Electrical Engineering, or related engineering discipline.
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• 7+ years of relevant manufacturing/process engineering experience, or an advanced degree with 5+ years of relevant experience.
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• Strong experience in a manufacturing or production environment.
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• Hands-on experience with process validation and equipment qualification.
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• Experience with semi-automated manufacturing equipment.
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• Experience with PLC-controlled equipment and machine interfaces.
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• Experience with machine vision / vision inspection systems.
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• Strong understanding of OEE, yield, throughput, capacity, scrap, and manufacturing performance metrics.
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• Experience with root cause analysis and continuous improvement.
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• Experience supporting NPI, manufacturing scale-up, production launch, or technology transfer.
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• Strong project planning, technical problem-solving, and cross-functional leadership skills.
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• Medical device, pharmaceutical, biotechnology, or other regulated manufacturing experience.
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• Experience with FDA Quality System Regulations.
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• Experience with ISO 13485.
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• Experience with plastic injection-molded components and welding/assembly processes.
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• Capital equipment and automation project experience.
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• Experience with manufacturing systems such as SAP or MES.
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• Experience with AutoCAD or SolidWorks.
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• Experience with Minitab or other statistical analysis tools.
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• Experience with manufacturing change control and CAPA.
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• Experience leading technical teams or mentoring engineers.
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Our client is a leading Healthcare 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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Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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