Job Title - R&D Engineer – Medical Device
Job Location - Santa Rosa, California (Fully Onsite)
Type: W2 Contract
Must Have:
Bachelor’s degree or higher in Engineering required
Minimum of 2 years of industry experience
Nice To Have:
Excellent communication skills, both written and verbal
Flexible and adaptable, comfortable working in a dynamic environment
Proficiency in engineering and scientific principles
Proficiency in SolidWorks
Self-starter and driver - able to execute effectively
Job Description -
This is an exciting opportunity to join the Structural Heart and Aortic operating unit to work with a dedicated team focused on the development of our new transcatheter heart valve replacement system. In this role, the engineer will be working on the delivery system team to develop and qualify the device.
A Day in the Life:
Design, develop, and optimize transcatheter heart valve delivery systems
Generate work instructions, test methods, engineering models, and drawings/prototypes to characterize product and process specifications
Develop a test strategy based on design requirements derived from the voice of the 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 on technical knowledge of the device and procedure
Develop project plans to manage the work individually and across multiple team members
Technical skills that are required for the role:
1. Root cause analysis experience
2. SolidWorks proficiency
3. Catheter device design (nice to have)
Education Required: Bachelor’s degree or higher in Mech/Biomedical Engineering required
Years’ Experience Required: Minimum of 2 years of industry experience
Responsibilities may include the following, and other duties may be assigned.
Designs, develops, analyzes, troubleshoots, and provides technical skills during research and/or product development.
Designs studies to investigate specific life science questions within the field of expertise.
May be involved in product research and development and/or clinical trials. Translate research discoveries into usable and marketable products.
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