Location: 100% onsite in Irvine, CA (Southern, CA) with projected travel or Santa Rosa, CA 3-5 days per month
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 an R&D Senior Engineer, you will be responsible for designing and developing a nitinol-based left atrial appendage (LAA) implant and closure system. This role will involve using your technical expertise with nitinol-based designs and problem-solving abilities to design, test, transfer to manufacturing, change management and support the clinical use of the product. 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 principles to product design and development
- Apply knowledge of nitinol material and processes to create specifications and fabricate parts
- Apply understanding of nitinol material and processes to write protocols, complete testing, and write reports
- Proactively identify issues and resolve them promptly
- Identify, evaluate, and manage external suppliers
- Understand manufacturing requirements and write work instructions
- Perform bench testing, cadaver studies, animal studies, and potentially support clinical studies
- Conduct failure analysis and provide recommended design improvements
- Cross-functionally collaborate with other functions: Quality, Operations Regulatory, and Clinical
- Train, coach, and guide lower-level employees.
Qualifications:
- A minimum of 5 – 7+ years of experience with BS or equivalent
- 3+ years relevant experience in research, design, and development of nitinol-based parts and assemblies
- Proven hands-on and technical aptitude for mechanical design, fabrication, and evaluation
- Experience with test method development and documentation
- Complex problem-solving ability
- Proficiency in 3D Solid Modeling and drawing
- Proficiency with Solidworks and statistical methods
- Excellent documentation and communication skills, both written and verbal
- Excellent soft skills and works well with others
- Responsible for forecasting and operating within a budget
- Flexible and adaptable – comfortable working in a dynamic environment
Preferred Qualifications:
- Experience with design of implantable devices and delivery systems
- Structural heart experience
- Vascular Experience
CA: Research & Development (R&D) Senior Engineer (2) (235870)
