RD Engineer

We are looking for a level II R&D Engineer.
-Onsite full time at Irvine, CA campus
-Time will be split 50/50 between working in the lab and office setting
Required skills:
-Proven prior experience working within a highly collaborative team environment
-Experience with Test Method Validation, Gage R&R, and basic CAD knowledge in a highly regulated environment
-Six Sigma certifications
-The ability to conduct statistical analysis with Excel and Minitab
-Prior experience with technical writing (basic level required)
Education/Experience:
Bachelor's degree in engineering required.
2-4 years experience required.
Lifesciences industry experience (i.e. medical device, pharma, or biotech)
Experience with design controls, design verification & validation, or design test method development
Demonstrated experience reviewing and updating risk management related documents
Experience utilizing statistical techniques to support design decisions and product acceptance testing
Person:
This role is responsible for leading and supporting key projects associated with our next generation transcatheter aortic system. This includes support of product configuration changes, owning design inputs and test methods associated with design verification and validation testing, and supporting critical investigations for the program.
Provide Engineering input to THV next generation projects including application of design control and risk management. Develop solutions to a variety or problems of moderate scope and complexity.
Apply mechanical and biomedical engineering principles to the design and development of components for the delivery system and accessories.
Develop test methods and procedures to evaluate device prototype performance.
Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
Build partnerships with key cross functional stakeholders
Maintain accurate documentation of concepts, designs, drawings, and procedures. Generate written protocols, reports, and technical justifications/summaries.
Creativity, verbal and written communication skills, analytical and problem solving ability.
Team player and detail oriented.
Previous experience with computer applications and software related to engineering field, such as Computer Aided Design (CAD).