Senior Medical Device 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

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