

Manufacturing Engineer II
Location
Irvine, CA
Level
Mid-Level
Department
MedTech
Type
Salary
Job Description
Posted on:
2025-06-06
The Manufacturing Engineer II will develop and implement manufacturing processes and methods, recommend improvements, and manage equipment lifecycle in a medical device environment.
Responsibilities
- Support manufacturing activities to meet safety, quality, cost, and production goals.
- Maintain systems for monitoring key performance indicators.
- Prepare product and process reports by analyzing information and trends.
- Perform installation and validation activities for production lines.
- Identify and purchase equipment according to production requirements.
- Coordinate calibration, maintenance, and repair services for equipment.
- Participate in continuous improvement projects for 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 with root cause problem-solving methodologies.
- Knowledge of FDA, GMP, and ISO guidelines.
- Ability to work independently and proactively identify improvement opportunities.