Design and development of transcatheter heart valves, manufacturing processes, and test methods used in the manufacturing and design characterization of medical device implants in a regulated environment. Activities will include heart valve frame design, testing, methods and process development, tooling design/fabrication, equipment design/fabrication, qualiﬁcation, validation, project management, failure analysis, regulatory submission, and documentation. Supports development projects in multi-functional project teams.
Implant Design · Design and implementation of new transcatheter heart valves based on user requirements speciﬁcations. · Designs implants for manufacturability · Generates new device concepts and product speciﬁcations. Ensures review of existing research, device concepts and data. Identiﬁes areas that require additional investigation. · Create and utilize models and ﬁnite element analysis to inform design iterations and testing conditions
Prototypes transcatheter heart valves. · Develops tooling and test equipment for manufacturing processes. Examples of pertinent duties include creating CAD drawings, equipment modeling, and speciﬁcations development.Creates, validates and performs test methodologies supporting design characterization for product development and regulatory submissions. · Familiarity with appropriate regulatory guidance documents and industry standards. · Performs data analysis (statistical and practical) and develops appropriate action plans based upon such analysis
- Speciﬁc knowledge of Domestic and International standards for Cardiac Valve prosthesis. ·Operator/Technician Supervisory Skills ·Design and testing of implantable heart valve frames ·Understanding of anatomical use and boundary conditions ·Knowledge of United States and International regulatory requirements (medical device, general), GMPs and industry standards/guidelines ·Knowledge of implantable materials and associated manufacturing processes for fabricating prototypes ·Experience with modeling and Finite Element Analysis ·Nitinol design, manufacturing, and testing skills ·Failure analysis experience ·Computer Skills: SolidWorks, AutoCAD, Microsoft Word, Excel, Project, PowerPoint; LabVIEW, Matlab ·Excellent verbal and written communication ·Custom instrumentation and laboratory automation ·Project management and planning ·Statistical Methods-FEA
- Ability to perform all assigned tasks, work independently, and complete work on schedule
- Ability to communicate effectively in multi-discipline, cross cultural environment and levels of organization
- Strong problem solving skills and efficient management of time and resources
Any specific industry experience