Job Function:
- Responsible for providing creativity to the mechanical engineering design and development of new invasive and non-invasive medical device products.
Description:
- Support Verification/Validation activities of Design.
- Assist in the design and fabrication of prototype hardware
- Prepare Documentation. Generate and review the technical content of drawings, engineering specifications, reports and other documentation associated with the mechanical design.
- Support Continuous Improvement.
- Acquire a working knowledge of ISO/QSR and the Mechanical Design Process.
- Acquire up-to-date knowledge of developments in mechanical engineering disciplines.
- Support to Sustainment. Provide Mechanical Engineering support to products in production.
- Manage material issues; perform root cause assessments of discovered issues. Perform analysis as required to verify validity of proposed solutions.
Other Essential knowledge, skills, and abilities:
- Ability to work well under pressure and to meet multiple and occasional competing deadlines while maintaining a cooperative working relationship with other employees and supervisor.
- Proficiency with CAD, word processing, spreadsheet, project management software applications.
- Ability to attend human clinical cases and interact the hospital staff in a constructive and professional manner.
- Knowledge of interventional medical products and technologies, especially catheters, vascular access devices and guide wires.
- Knowledge of medical device industry regulatory requirements including design and control practices, GMP’s and GLP’s.
Training and Experience Required:
- a minimum of two (2) years work experience medical design/ experience in medical device/clinical environment.
Education:
- Bachelor's Degree in Mechanical Engineering preferred and/or a Master's Degree
WORKING ENVIRONMENT:
- Job duties are primarily performed in an office environment utilizing standard office equipment such as a computer, photocopier, and telephone. The noise level in the work environment is usually low to moderate.
- May require some job duties to be performed in a laboratory environment that requires special clothing and practices and requires strict adherence to departmental and standard operating procedures. Occasionally requires some job duties to be performed at animal and human cadaver studies as well as live human cases.