Job :: Mechanical Design Engineer
Location ::Irvine, California (ONSITE)
Technical/Functional Skills | Mechanical Engineering, SolidWorks, FDA regulations, GD&T, Tolerance stackup |
Experience Required | - Bachelor's Degree, preferably in Mechanical Engineering or other related engineering degree.
- 2 plus years of medical device engineering experience highly preferred.
- Knowledge of FDA 21CFR820 Quality System Regulation for developing and qualifying a medical device.
- Strong knowledge of Mechanical CAD design using SOLIDWORKS.
Strong oral and written communication skills. Experience in managing project teams across geographies (onsite/offshore) Cross-functionally and an effective team player. - Knowledge on GD&T and tolerance stackup.
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Roles & Responsibilities | - Responsible for effective communication between the project team and the customer.
- Responsible for project requirements gathering and coordination with offshore team.
- Provide day to day direction to the project team (TCS onsite/offshore) and regular project status to the customer.
- Responsible to support client technical teams to in design and development of mechanical and electro-mechanical functionality of medical devices.
- Perform root cause analysis and drive change implementation for Engineering changes and Supplier Change Requests.
- Managing and creating project artifacts, planning, tracking, change control, aspects of the project life cycle.
- Interacting with the client regarding daily activities, work status and clarifications on the requirement.
- Perform design analyses and assessments.
Execute design characterization and design verification and validation testing. - CAD modelling using SolidWorks.
- Coordinate with offshore team members to develop detailed engineering specifications, CAD models, drawings, change orders, design & development, verification, validation, and production support.
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Generic Managerial Skills | - Excellent interpersonal and communication skills with ability to effectively interface with technical personnel at various levels of the organization
- Demonstrated excellent communication skills orally, written and presentation group settings
- Demonstrated teamwork and problem-solving skills
- Demonstrated ability to take ownership of a problem and drive to implement at solution as an individual and as a team player
- Ability to act quickly and decisively
- Ability to develop relationship with customer and work with customer and TCS management to help each other's business growth.
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Education | Technical/Engineering Degree |