Job Title - Sr R/D Engineer
Job Location -Santa Rosa, California
HM's Top Needs:
- Candidate with some level of industry experience in Bio-Tech or Medical Devices industry.
- Good problem-solving skills with experience in performing root-cause analysis.
- Hands-on experience with test method development, fixture design and mechanical component design.
A Day of in the Life:
- Design, develop and optimize transcatheter heart valve catheter delivery systems
- Develop deep understanding of procedure through cadaver and animal studies to refine device usage and procedural aspects in partnership with physicians; provide support to clinical trials as needed
- Manage product interfaces across implant, catheter, accessories and packaging, including setting up requirements flow and ensuring design changes are properly evaluated
- Generate work instructions, test methods, engineering models and drawings/prototypes to characterize product and process specifications
- Develop test methods to verify product performance is as intended
- Develop test strategy based on design requirements derived from voice of customer, and execute on protocol, testing, data analysis, and reports required for regulatory submissions
- Identify issues, conduct root cause analysis, and map out resolution when designing parts, components and sub-assemblies using engineering first principles and appropriate test evaluations
- Create and update design control documents, including updating risk analysis documents, based upon technical knowledge of device and procedure
- Support delivery system builds by addressing questions, conducting root cause analysis as required and leading issue resolution
- Support clinical trials through physician/site training and providing case support
- Develop project plan to manage the work individually and across multiple team members
- Contribute to defining the direction for new products, processes, standards, or operational plans based on business strategy
- Communicate with internal and external customers and vendors at various levels; represent work through internal conferences and collaborations across multiple business units and functions.
