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