Manufacturing Engineer II
Location
Irvine, CA
Level
Mid-Level
Department
MedTech
Type
Salary
Job Description
Posted on:
2025-06-06
Responsibilities
- Support manufacturing activities to meet safety, quality, cost, and production goals.
- Maintain systems for monitoring key performance indicators.
- Adhere to medical device manufacturing standards and regulations.
- Prepare product and process reports by analyzing trends.
- Perform installation and validation activities for production lines.
- Identify, select, and purchase equipment based on production requirements.
- Lead or support continuous improvement projects in safety, quality, and production.
Job Requirements
- Bachelor's Degree in Engineering or related field.
- 2-4 years of medical device engineering experience.
- Knowledge of statistical techniques (DOE, SPC).
- Proficiency in Microsoft Office software.
- Experience in medical device manufacturing and process improvement.
- Familiarity with FDA, GMP, and ISO guidelines.
- Strong problem-solving skills, particularly in root cause analysis.
