Our client is seeking a Principal Mechanical Engineer / Director to lead and coordinate the design & development of a complex medical robotic system and associated accessories. The ideal candidate will be self-motivated and take ownership of the product design, clinical performance, and transfer to manufacturing being the primary interface between the R&D, clinical, and manufacturing teams. Later supporting the deployment of the robotic system in the field and managing the continuous improvement programs. Looking for a self-motivated, proactive, well rounded individual willing to take ownership and operate with minimal supervision in a fast-paced startup environment.

Responsibilities:

• Leading the design and development of complex multi-axis medical robotic systems
• Act as the interface between the R&D and manufacturing team for seamless rollout of product to manufacturing
• Coordinate with the supply chain team and external vendors to procure critical components
• Design and develop assembly/testing tools/fixtures to aid in the assembly process and conduct in-process manufacturing quality assurance
• Participate and lead design reviews, dFMEA and other design de-risking activities
• Lead continuous improvement programs to improve the performance of the robot and/or reduce the cost and complexity of the system
• Manage and mentor younger engineers to reach their full potential

Requirements:

• Design ownership for multi-axis robotic systems for use in advanced surgical procedures
• Package electro-mechanical components including motors, gearboxes, motor controllers and compute into tight foam factor, considering sealing requirements for fluid ingress, EMC performance and thermal management
• Design and develop automated testing devices and fixtures to conduct functional and reliability tests on robotic subsystems
• 6-12 years of experience in design and development of complex capital equipment
• At least 5 years of experience in development of medical devices capital equipment
• Deep knowledge in at least one or more of the following domains - servo motors and actuators, welded frames and mechanical structures, precision machined components, sheet metal design, or injection molded and thermoformed plastics, DFM
• Demonstrated ability to be successful in supporting multiple sub-projects concurrently
• Ability to juggle multiple priorities based on the criticality of the project deliverables
• Experience transferring design to manufacturing including detailed drawing and assembly instructions
• Experience with risk analysis, risk mitigation and dFMEA practices to perform dFMEA and Hazard analysis to mitigate risks in design concepts
• Demonstrated experience working with multi-disciplinary, cross functional teams
• Advanced SolidWorks user with at least 5 years of experience
• Experience with PLM systems such as Agile or similar
• Knowledge of regulatory standards such as IEC 60601-1 and FDA 510 (k) submission process
• Must have prior experience working in a fast-paced startup environment working collaboratively and efficiently with minimal supervision and guidance
• Excellent communication (verbal and written), interpersonal and negotiation skills; friendly and approachable.
• Strong team player with demonstrated history of success working in a multi-disciplinary, cross-functional environment
• B.S. degree in Mechanical, Bio-medical or related discipline. M.S degree preferred