Location:
- 100% onsite, Northern California
Job Description:
As an R&D Engineer will be responsible for the design and design and development of a left atrial appendage (LAA) closure system. Your role will involve using your technical expertise and problem solving abilities to design, test, transfer to manufacturing, and support the clinical use of the product. Your ability to rapidly respond to issues as part of a cross functional team to sustain the production of clinical product will be critical. You will also interact with suppliers at various levels to support the design and manufacturing of the product.
Responsibilities:
Technical Design & Development
- Apply mechanical and biomedical engineering first principles to product design and development
- Design, prototype, and manufacture transcatheter components and assemblies
- Proactively identify issues and resolve them in a timely manner
- Complete root cause analysis, evaluations, and reports
- Create and perform experiments to evaluate the design performance
- Contribute to design documents, establish tolerances, and define specifications
- Develop and execute test protocols and write up results
- Understand manufacturing requirements and write work instructions
- Perform bench testing
- Contribute technical content necessary to close non-conforming material reports
- Cross-functionally collaborate with other functions: Quality, Operations Regulatory, and Clinical
Qualifications:
- Required:
- A minimum of 3 – 5 years of experience with BS or equivalent, 0-2 years with an MS degree.
- 1+ years of relevant experience in research, design, and development
- Proven hands-on and technical aptitude for mechanical design, fabrication, and evaluation
- Proficiency with Solidworks
- Experience conducting testing and recording data in lab notebook
- Excellent soft skills and works well with others
- Flexible and adaptable – comfortable working in a dynamic environment
- Self-starter, able to make progress on engineering problems with limited oversight
- Preferred:
- Experience with design of implantable devices and transcatheter delivery systems
- Experience supporting manufacturing processes
- Experience operating within a Quality Management System
US: Research & Development Engineer (4) (235871)
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