Sr. Manufacturing Engineer

Job Description

CODAN US Corporation

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San Diego, CA / Tijuana, MX

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Full-Time | On-Site

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Salary Range: $100,000–$130,000 per year

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CODAN US Corporation is a manufacturer and distributor of IV therapy and infusion sets serving hospitals, integrated delivery networks, and medical device OEMs across North America and global markets.

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For over 50 years, CODAN has provided IV administration sets, specialty anesthesia sets, blood collection systems, custom manifolds, enteral feeding solutions, and other medical device products.

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We are seeking an experienced Senior Manufacturing Engineer to provide technical leadership for our medical device manufacturing operations.

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This position will be responsible for developing, validating, optimizing, and continuously improving manufacturing processes, production equipment, and automation systems. The Senior Production Engineer will work closely with Manufacturing, Quality, Regulatory, Supply Chain, Maintenance, and Operations teams to improve product quality, production efficiency, capacity, and cost while maintaining compliance with applicable medical device regulations and quality standards.

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Responsibilities

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• Lead the development, qualification, validation, implementation, and optimization of manufacturing processes, production equipment, and automation systems.
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• Lead equipment qualification and process validation activities, including IQ, OQ, and PQ.
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• Support new product introductions, product transfers, and manufacturing-readiness activities.
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• Identify and implement improvements to manufacturing processes, equipment, productivity, quality, and cost.
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• Lead troubleshooting and root cause analysis for manufacturing, equipment, and product-quality issues.
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• Analyze manufacturing data and metrics, including yield, scrap, downtime, cycle time, labor efficiency, equipment utilization, and process capability.
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• Lead or support CAPA, nonconformance investigations, customer complaints, and corrective actions.
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• Develop and maintain engineering and manufacturing documentation, including SOPs, work instructions, validation protocols and reports, process specifications, risk assessments, and control plans.
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• Support change-control activities and evaluate the manufacturing impact of product, material, supplier, equipment, and process changes.
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• Apply Lean Manufacturing, Value Stream Mapping, Kaizen, DFM, and DFA principles to improve manufacturing processes.
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• Lead automation, continuous improvement, value engineering, and cost-reduction projects.
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• Support production capacity planning, line balancing, manufacturing layout, and equipment-selection activities.
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• Collaborate with Quality Assurance, Regulatory Affairs, Manufacturing, Operations, Maintenance, and Supply Chain teams.
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• Participate in internal, customer, supplier, and regulatory audits.
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• Provide technical mentorship and guidance to engineers, technicians, and manufacturing personnel.
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• Manage assigned engineering projects according to scope, schedule, budget, quality, and compliance requirements.
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• Stay current with industry trends, emerging technologies, regulatory requirements, and manufacturing best practices.
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• Perform other duties and special projects as assigned.
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Qualifications

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• Bachelor's degree in Mechanical, Industrial, Manufacturing Engineering, or a related field.
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• Minimum 8 years of engineering experience, preferably in medical device or regulated manufacturing.
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• Experience with medical device quality systems, including ISO 13485 and FDA 21 CFR Part 820/QMSR.
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• Experience with process validation, equipment qualification, root cause analysis, and corrective actions.
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• Knowledge of Lean Manufacturing, Kaizen, Value Stream Mapping, and continuous improvement.
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• Experience with PFMEA, control plans, and risk-management methodologies.
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• Experience with ERP/MRP systems; Microsoft Dynamics 365 preferred.
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• Proficiency with SolidWorks, AutoCAD, or similar engineering software.
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• Strong analytical, problem-solving, organizational, and communication skills.
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• Experience leading cross-functional engineering projects.
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• Fluent in English and Spanish.
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• Willingness and ability to regularly travel to and work at our manufacturing facility in Tijuana, Mexico.
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• Medical device manufacturing experience.
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• Experience with DFM/DFA.
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• Experience with product transfers and manufacturing scale-up.
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• Experience supporting regulatory and customer audits.
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This position is based in San Diego, CA but required daily travel to CODAN's manufacturing facility in Tijuana, MX.