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Senior R&D Engineer
2 months ago
LanceSoft is seeking a highly skilled Senior R&D Engineer to join our team. As a key member of our engineering team, you will be responsible for designing, developing, and optimizing transcatheter heart valve catheter delivery systems.
Key Responsibilities:- Design and develop 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
- Manage product interfaces across implant, catheter, accessories, and packaging
- 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
- Bachelor's degree in a technically related field required, preferably mechanical engineering or biomedical engineering
- Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
- Good problem-solving skills with experience in performing root-cause analysis
- Hands-on experience with test method development, fixture design, and mechanical component design
- Ability to work well with others and communicate effectively through written and verbal means
This is a full-time position that requires working on-site in Santa Rosa, California. The ideal candidate will have a strong understanding of medical device development and a passion for innovation.
