Sr. Manufacturing Engineer

CODAN US Corporation; San Diego (CA); On-site; USD 100,000 - 130,000; Full time

Job summary

CODAN US Corporation, based in San Diego, seeks a Senior Manufacturing Engineer to provide technical leadership for medical device manufacturing. The role develops, validates, and optimizes processes, equipment, and automation across QA, Regulatory, Supply Chain, and Operations teams.

The candidate will lead qualification activities (IQ/OQ/PQ), support new product introductions, and drive Lean initiatives to improve yield, efficiency, and cost while ensuring compliance with ISO 13485 and FDA

Qualifications

• Bachelor’s degree in an engineering field (Mechanical/Industrial/Manufacturing).
• 8+ years in engineering, preferably in medical device manufacturing.
• Experience with ISO 13485 and FDA 21 CFR Part 820/QMSR.
• Knowledge of Lean, Kaizen, Value Stream Mapping, and continuous improvement.
• Experience with PFMEA, control plans, and risk-management methodologies.

Responsibilities

• Lead development, qualification, validation, implementation, and optimization of manufacturing processes and automation.
• Lead equipment qualification and process validation (IQ, OQ, PQ).
• Support new product introductions, transfers, and manufacturing-readiness activities.
• Identify and implement improvements to processes, equipment, productivity, quality, and cost.
• Lead troubleshooting and root cause analysis for manufacturing and product-quality issues.
• Analyze manufacturing data: yield, scrap, downtime, cycle time, labor efficiency, utilization.

Skills

Lean Manufacturing

Kaizen

Value Stream Mapping

Process Validation

Root Cause Analysis

CAPA

ERP/MRP (Dynamics)

SolidWorks

AutoCAD

Analytical Skills

Cross-functional Leadership

Bilingual EN/ES

Education

Bachelor's degree in Mechanical/Industrial/Manufacturing Engineering

Tools

SolidWorks

AutoCAD

Microsoft Dynamics 365

Job description

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

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.

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.

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

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.

Responsibilities

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

Qualifications

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

This position is based in San Diego, CA but required daily travel to CODAN's manufacturing facility in Tijuana, MX.