Location: 100% onsite in Either Santa Rosa, CA (Northern, CA) or Irvine, CA (Southern, CA)
Job Description:
- This Client is a clinical-stage medical device company advancing transseptal left atrial appendage (LAA) closure in the process of a design transfer.
- Client is looking for 4 R&D Engineers (Mid-level – 4-10+ years of experience) that will be responsible for the design and design and development of a left atrial appendage (LAA) closure system.
- This role will involve technical expertise and problem-solving abilities to design, test, transfer to manufacturing, and support the clinical use of the product. The ability to rapidly respond to issues as part of a cross functional team to sustain the production of clinical product will be critical. This person will interact with suppliers at various levels to support the design and manufacturing of the product.
Responsibilities:
- Technical Design & Development:
- Apply mechanical and biomedical engineering principles to product design and development
- 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
- Write design documents, establish tolerances, and define specifications
- Identify, evaluate and manage external suppliers
- 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:
- A minimum of 4-10+ years of experience with BS or equivalent
Proven hands-on and technical aptitude for mechanical design, fabrication, and evaluation
Experience conducting testing, recording data, and drafting reports
Demonstrated understanding of engineering first principles
Proficiency in 3D Solid Modeling and drawing
Excellent documentation and communication skills, both written and verbal
Excellent soft skills and works well with others
Flexible and adaptable – comfortable working in a dynamic environment
Preferred Qualifications:
- Proficiency with Solidworks and statistical methods
- Experience with design of implantable devices and delivery systems
- Structural heart experience
- Nitinol-based parts and assemblies
- Vascular Experience
US: Research & Development Engineer (4) (235871)
