Job Description

ZENFLOW, INC.

395 OYSTER POINT BOULEVARD, SUITE 501

SOUTH SAN FRANCISCO, CA 94080

PRINCIPAL R&D ENGINEER - ENDOSCOPY

DESCRIPTION:

This role is for a hands-on Principal-Level R&D Engineer to help commercial-scale development of a proprietary single-use flexible digital cystoscope and associated hardware. This team member will primarily be responsible for identifying and implementing key design changes required to improve the scalability and COGS of an existing cystoscope and hardware platform.  

RESPONSIBILITIES:

This Principal R&D Engineer team member will be responsible for product development from concept to implementation.

• Concept ideation/brainstorming, based on known customer requirements and manufacturing scalability challenges

• Prototyping and building at small scales to demonstrate concept/design feasibility

• Verification/validation activities, including specification and test method development

• Producing and maintaining quality system documentation, including design history files and device master records, per FDA QSR requirements

• Working with vendors and external resources to design and procure components and subassemblies, as necessary

• Participates and contributes to system-level project discussions, and trains/provides guidance and leadership to technicians and less-experienced members of the R&D team

• Works collaboratively with Regulatory, Operations, and Quality at all stages of development, as needed

REQUIRED QUALIFICATIONS:

• BS in Mechanical Engineering, Electrical Engineering, or Biomedical engineering
• 10+ years of experience as an R&D engineer in the medical device industry. Experience in academic research will not be considered toward the minimum.
• Experience developing commercial-scale endoscope technology, including hardware
• High level of proficiency in SolidWorks for mechanical design as well as OrCAD or similar for PCB design
• Track record of adherence and compliance to FDA and other regulatory standards

PREFERRED QUALIFICATIONS:

• Experience in CMOS-based digital endoscope development
• Experience developing catheter-based technologies, and familiarity with catheter manufacturing processes (extrusions, braiding, etc).
• Experience in designing machined and injection-molded components
• Experience in product development from a clinical to commercial phase

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