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Research And Development Engineer
3 months ago
Job Title: R-D Engineer (Medical Devices)
Job Location: Santa Rosa, California (Fully Onsite)
Type: W2 contract
Job Description:
Candidate with some level of industry experience in Bio-Tech or Medical Devices industry
Good problem-solving skills with experience in performing root-cause analysis
Hands-on experience with test method development, fixture design and mechanical component design.
Education Required: Bachelor’s degree in a technically related field required preferably mechanical engineering or biomedical engineering
Years’ Experience Required: Minimum of 2 years of relevant experience, or advanced degree with a minimum of 0 years relevant experience.
Design, develop and optimize transcatheter heart valve delivery systems
Develop deep understanding of procedure through cadaver and animal studies to refine device usage and procedural aspects in partnership with physicians; provide support to clinical trials as needed
Generate work instructions, test methods, engineering models and drawings/prototypes to characterize product and process specifications
Develop test strategy based on design requirements derived from voice of 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 upon technical knowledge of device and procedure
Develop project plan to manage the work individually and across multiple team members.