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.
Job ID:26-29669
Pay Range: $100 - $103/hour. Traveler benefits as per agency package. (Benefits vary by vendor and assignment.)
Key Responsibilities:- Provide technical leadership and engineering ownership for manufacturing and production lines.
- Support manufacturing line launch, NPI, production ramp-up, and hypercare activities.
- Develop, optimize, and improve manufacturing processes, production layouts, equipment, tooling, and assembly operations.
- Lead process validation and equipment qualification activities.
- Support installation, integration, commissioning, and optimization of manufacturing equipment.
- Troubleshoot and improve semi-automated manufacturing equipment, PLC-controlled systems, machine interfaces, and vision inspection systems.
- Analyze production performance using OEE, yield, throughput, capacity, scrap, and efficiency metrics.
- Identify opportunities to improve manufacturing capacity, quality, yield, and overall equipment effectiveness.
- Apply SPC, statistical analysis, root cause analysis, and continuous improvement methodologies to manufacturing problems.
- Lead technical investigations and corrective actions related to equipment, process, and quality issues.
- Support manufacturing changes through appropriate change-control and engineering documentation processes.
- Partner with Quality to ensure compliance with applicable FDA Quality System Regulations and ISO 13485 requirements.
- Support manufacturing scale-up, technology transfer, process development, and product launches.
- Provide technical leadership for capital equipment, automation, and manufacturing technology projects.
- Evaluate manufacturing equipment, tools, processes, and technologies for performance, reliability, and scalability.
- Develop manufacturing procedures, process documentation, validation documentation, and technical reports.
- Collaborate with Operations, Quality, R&D, Supply Chain, and other stakeholders to resolve manufacturing challenges.
- Mentor and provide technical guidance to Manufacturing Engineers and Process Engineers.
Key Requirements and Technology Experience:- Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, Electrical Engineering, or related engineering discipline.
- 7+ years of relevant manufacturing/process engineering experience, or an advanced degree with 5+ years of relevant experience.
- Strong experience in a manufacturing or production environment.
- Hands-on experience with process validation and equipment qualification.
- Experience with semi-automated manufacturing equipment.
- Experience with PLC-controlled equipment and machine interfaces.
- Experience with machine vision / vision inspection systems.
- Strong understanding of OEE, yield, throughput, capacity, scrap, and manufacturing performance metrics.
- Experience with root cause analysis and continuous improvement.
- Experience supporting NPI, manufacturing scale-up, production launch, or technology transfer.
- Strong project planning, technical problem-solving, and cross-functional leadership skills.
- Medical device, pharmaceutical, biotechnology, or other regulated manufacturing experience.
- Experience with FDA Quality System Regulations.
- Experience with ISO 13485.
- Experience with plastic injection-molded components and welding/assembly processes.
- Capital equipment and automation project experience.
- Experience with manufacturing systems such as SAP or MES.
- Experience with AutoCAD or SolidWorks.
- Experience with Minitab or other statistical analysis tools.
- Experience with manufacturing change control and CAPA.
- Experience leading technical teams or mentoring engineers.
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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