Job Title - R-D Engineer II
Job Location - Santa Rosa, California
Duration 12 Months
Job Description -
HM's Top Needs:
- 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.
- 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