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Product Development Engineer - Berkeley, United States - Gravitas Medical
Description
JOB TITLE: Product Development Engineer
COMPANY DESCRIPTION
Gravitas Medical is revolutionizing enteral feeding with an FDA cleared smart nasogastric feeding system. See for more information.
POSITION DESCRIPTION
The Product Development Engineering position supports all product development engineering activities including but not limited to design, testing and manufacturing of the Gravitas nasogastric feeding tube system.
ESSENTIAL FUNCTIONS
Lead an engineering project through design control, providing regular updates and delivering to mutually agreed upon milestone dates
Design fixtures and develop procedures to manufacture the Gravitas nasogastric feeding tube system. Make recommendations based on data and quantitative analysis.
Perform inspection on components and assemblies used to manufacture medical devices.
Perform device design reliability engineering activities including test equipment and fixture design, test setup, data analysis and reporting.
Develop and execute test methods to benchmark the Gravitas system compared to commercially available products.
Develop and perform verification testing and product validation testing
Work with outside vendors to manufacture components and subassemblies that comply with the Gravitas QMS
Prepare technical product documentation including design history files, drawings, bill of materials, test protocols and reports, engineering change orders, etc while complying with the Gravitas QMS.
Drive hands-on fabrication and testing of prototypes using bench testing, animal and/or cadaver studies to evaluate product designs, and recommend and implement design modifications.
REQUIREMENTS
Minimum of a bachelors degree in mechanical engineering, bioengineering or similar field is required. Masters degree is preferred.
Minimum of 3 years medical device industry engineering experience. Catheter or gastric device experience is a plus.
Proficient in CAD, preferably SolidWorks
OTHER QUALIFICATIONS
Startup experience preferred. Willing to take on responsibilities that are outside of this job description and will do what it takes to get the job done.
Manufacturing transfer, validation and process optimization is a plus
Interpersonal written and verbal communication skills.
Strong team-working and communication skills. A drive to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed.
Competent using office software including MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.
Proficient prototyping concepts and working in the machine shop.
Instron use and Instron test method programming is a plus
LabVIEW experience, and general programming experience is a plus
Robotic and electromechanical device/fixture design experience is a plus
Laser welding experience is a plus
3D printing experience is a plus
