Deisgn Engineer â Process Validation and Development
Deisgn Engineer â Process Validation and Development
Posted on :
14-07-2025
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1 Vacancy
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Job Description
Title: Deisgn Engineer Process Validation and Development
Location: Irvine - CA
JD:
Location: Irvine - CA
JD:
- A minimum of a Bachelors degree is required preferably in Engineering combined with at least 3 years work-related experience
- Previous experience in the areas of Design for Manufacturing or Assembly
- Experience working closely with external suppliers (Required)
- Performance within a medical device production environment or other regulated environment (Preferred)
- Knowledge of good manufacturing practices and documentation preferably in the medical industry.
- Good in Fixture design and development
- Measurement Systems Analysis (i.e. GR&R)
- Hands-on in Solidworks
- Perform engineering study for concepts proposed and demonstrate feasibility with data samples simulations or prototypes.
- Identifies designs and develops the necessary equipment related to new product development.
- Studies the existing processes to implement improvements on new process.
- Responsible for preparing and managing specifications.
- Performs activities of process/product validation.
- Concept Development
- Preparation of Drawing and Models in Solidworks
- Additional Duties:
- Responsible for communicating business related issues or opportunities to next management level
- Responsible for following all Company guidelines related to Health Safety and Environmental practices as applicable.
- For those who supervise or manage a staff responsible for ensuring that subordinates follow all Company guidelines related to Health Safety and Environmental practices and that all resources needed to do so are available and in good condition if applicable
- Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures
- Performs other duties assigned as needed
Mandatory Skills:
- Fixture / Equipment design development qualification for mechanical electromechanical Components - Handon Exp is preferred
- Solidworks : Experience in Modelling and Detailing
- Medical Device experience : Medical device documentation and product experience
Employment Type
Full-time
Key Skills
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