Member of Technical Staff
- Perform design verification activities to ensure that design outputs conform to design inputs, and validation activities to ensure that the finished product fulfills user requirement.
- Create, review and update Legacy Risk management documents such as Design Failure Mode and Effect Analysis (DFMEA) and Process Failure Mode and Effect Analysis (PFMEA) of Trauma and CMF Implant and instrument families (class I and class II) to comply with the current FDA, TUV and ISO standards.
- Use AutoCAD, Autovue, Creoview and Solid works to evaluate design, drawings and models for risk analysis and find suitable risk controls and document them in DFMEA and PFMEA.
- Generate mechanical test reports that evaluate applicable yield strength, tensile strength and material wear, and corrosion characteristics for verification.
- Participate in saw bone testing, cadaver lab testing, for design validation of the medical devices.
- Participate in activities towards improving existing design and process while maintaining QSR and cGMP compliance. Review Post market surveillance plan and reports for the trauma and CMF devices, and supply advice to update them if deemed necessary.
- Use Excel and Minitab for the data analysis of the sales and complaint of existing devices and find occurrence rates of harms from the analysis based on the complaints to sales analysis for a particular period.
- Travel and relocation possible to unanticipated client locations throughout the U.S.
Required Skills & Experience:
- Master’s or foreign equivalent degree in Mechanical Engineering or Industrial Engineering and 2 years of experience in the job offered or 2 years of experience with AutoCAD, Autovue, Creoview, Microsoft suite of products, Minitab, Agile, Windchill, Solidworks, and Docusphere. Travel and relocation possible to unanticipated client locations throughout the U.S.
- Clearwater, FL and unanticipated client locations throughout the U.S.
- Highly competitive to match experience and capability