- The candidate will support product development activities for medical devices and their components, including mechanical components and assembly design, fixture design, preparation and submitting tests requests, execution of product and material testing, analysis of results, and assistance in the generation of final technical report. The candidate must follow Corporate and Divisional Quality systems and comply with all regulatory and safety guidelines.
- Conduct lab testing and experiments including but not limited to: Collect and prepare samples; Make standard observations and perform standard tests according to documented procedures; Perform simple data analysis (preferably in Minitab).
- Write protocols/test requests, coordinate execution and write test reports for engineering studies.
- Interfaces directly with appropriate R&D, QA, core team, and manufacturing personnel on the status and findings of investigations performed in the laboratory.
- Develop or modify designs and 2D drawings for mechanical component and assembly design, testing fixtures and testing components using CAD software (SolidWorks).
- Assist the preparation of technical reports and presentations of experimental work product.
Education and Experience:
- Minimum BS/BE in Mechanical, Biomedical, Materials or Chemical Engineering or related field.
- 2+ years of experience supporting projects in product development or science/engineering research. Especially hands-on experience with design and development of high volume disposable medical devices is highly desirable.
- Demonstrated basic mechanical design skills using CAD (SolidWorks preferred) for 3D modeling and 2D drawing.
- Understanding of testing and measurement systems. Experience with lab testing and experiments is highly desirable.
- Demonstrated protocol/procedure development for engineering studies, including mechanical and material testing.
- Strong interpersonal and communication skills.
- Careful attention to detail to ensure accurate and precise execution of work tasks and procedures.
- Disciplined and well organized in documentation in a regulated environment.
- Ability to analyze and organize data in a clear and concise manner.
- Must adapt rapidly to changing work assignments.