Mechanical Design Engineer

Job Title

R&D Mechanical Design Engineer

Relevant Experience

(in Yrs)

5-7 Years

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.

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.

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.