Principal Engineer , R&D

PROCEPT BioRobotics•San Jose, CA

1d•$221,780 - $260,920

About The Position

The Principal R&D Engineer will assist and lead the Product Development and Advanced Engineering group activities relevant to the transfer of technology to commercial manufacturing. This includes design, development, and testing of an accessory, component, and/or sub-assemblies of the commercial Aquablation Robotic System. This individual leads the transition of all PROCEPT BioRobotics products from any supply source into full production release and market launch.

Requirements

BSME required, MSME preferred.
Minimum of 12 years of working experience with medical devices, robotic surgery systems, and/or medical implants.
Strong leadership skills with a proven ability to manage multiple technical projects effectively.
Highly desirable for a product minded individual, with the ability to combine complex mechanical systems into a product that meets or exceeds patient and physician needs.
Extensive experience with all phases of the product development lifecycle including design, implementation, verification, qualification, and transfer to manufacturing.
Proficiency using CAD to design and document mechanisms: SolidWorks (required).
Strong understanding of component selection criteria, and design for reliability and manufacturability.
Demonstrated ability to design for manufacturing and assembly (DFx).
Proven experience with developing criteria for outsourced products and the subsequent managing of those programs.
Experience with designing surgical products in an FDA or other regulated industry; strong experience with concepts of design input, design output, traceability, and risk analysis.
Ability to communicate effectively (written, oral) across all levels and organizations.
Mechanical design and analysis skills, including statics, dynamics, kinematics, strength of materials and stress analysis.

Responsibilities

Lead design teams, provide technical leadership, and facilitate the successful execution of the Design Control and Quality Engineering Processes.
Oversee product development activities from concept to regulatory approval.
Collaborate with other engineering disciplines (software, electrical, systems, manufacturing) on the design and development of consumables and accessories.
Provide design, integration and test solutions in a fast-paced environment with a quick development cycle.
Identify and resolve technical issues to ensure feasibility and sustainability of products.
Perform technical design reviews to solicit feedback on design progress
Work closely with cross-functional departments to develop robust, scalable assembly processes that are cost-efficient and ready for high volume production.
Support prototype clinical devices in the field.
Make decisions based on risk assessment, industry standards, and regulatory framework.
Assist in the development of manufacturing fixtures and instrumentation.
Collaborate and lead design initiatives with outside consultants.
Interface with vendors in a lead role, for component sourcing and fabrication.
Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance.
Understand and adhere to the PROCEPT BioRobotics Quality Policy & EHS Policies