job_021422a: Half Moon Medical - Principal Engineer (Menlo Park, CA)

From: Kristin Burns <kburns_at_stanford.edu>
Date: Mon, 14 Feb 2022 16:33:23 +0000

Half Moon Medical agrees with Stanford's employer recruiting guidelines.
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ABOUT HALF MOON MEDICAL
Half Moon Medical is a medical device start-up out of The Foundry, the Bay Area's premier medical device incubator. Half Moon Medical is backed by a strategic and is developing a novel catheter based mitral valve repair device.

POSITION SUMMARY
Half Moon Medical is seeking a strong medical device engineer with experience in implant design and structural reliability. The engineer will be a senior member of the research & development team responsible for development/implementation of the mechanical and fatigue testing strategy for the Half Moon implant. The engineer will be required to guide and mentor other engineers and technicians and work with cross functional team members and various vendors and suppliers.

PRINCIPAL DUTIES AND RESPONSIBILITIES
* Develop and manage the structural reliability plan for the Half Moon implant
* Provide key design input towards optimizing the performance and durability of the Half Moon implant
* Develop & manage mechanical and fatigue testing on devices and components using cyclic load fatigue testers/ hydrodynamic testers
* Create appropriate models and test methods for mechanical and fatigue testing including methods for measuring implant deflections as inputs for boundary conditions for FEA and structural integrity testing
* Manage and work with consultant(s) to develop & execute FEA models for implant iteration and structural integrity testing
* Develop and document test protocols/methods and engineering reports on implant functional performance and durability
* Presentation of test strategy and results to FDA and clinical partners
* Technical report writing for structural reliability and durability sections of regulatory submissions
* Fracture analysis of nitinol/ Co-Cr components, as applicable
* Analysis of failure modes from testing and clinical use, as applicable. Root cause analyses and replication of hemodynamic performance in appropriate models
* Contribute to the intellectual property via invention & patent disclosures. Maintain accurate documentation of concepts, designs &, drawings
* Provide project updates at company and Board of Director's meetings as required

EXPERIENCE REQUIREMENTS
* 10+ years medical device industry or relevant academic experience
* 3+ years of FEA project experience preferred

EDUCATION REQUIREMENTS
* A technical or life sciences undergraduate degree from an accredited university
* Advanced engineering or science degree, or fellowship experience preferred

OTHER QUALIFICATIONS
* Excellent written & verbal communication skills
* Knowledge of and experience in development of medical devices in conformance with Quality System Regulations and ISO requirements
* Knowledge of analytical tools and methods, including statistics, DOE and the use of computer/software packages (Solidworks, Abaqus) related to FEA, design, and development

CONTACT
* Gaurav Krishnamurthy, COO
* gkrishnamurthy_at_thefoundry.com
* Menlo Park, CA
Received on 2022-02-14 08:33:29