Senior Mechanical Engineer, Instruments

Job description

Primary Function of Position The Senior Mechanical Engineer, Instruments, is responsible for the technical development of advanced energy products at Intuitive. Their focus will be on the mechanical/electrical design of advanced energy catheters and instruments, contributing to the exploration of a novel system concept for a new application of surgical robotics. They will be a responsible member of the Advanced Research team supporting innovative technology development and commercialization.

They will have both the technical depth to resolve complex mechanical, material, and manufacturing design issues as well as the ability to work in an interdisciplinary team to troubleshoot and root cause higher level system issues. They must have strong technical depth in relevant areas and have a track record of successful product development efforts. Using their subject matter expertise, exceptional communication skills and cross-functional collaboration, they will investigate and develop advanced energy applications for novel clinical applications across our robotic surgical systems.

They must excel in a high-energy, focused, small-team environment, and have a commitment to high quality prototypes and concepts. A strong sense of shared responsibility and shared reward is required as well as a commitment to high product quality.

Essential Job Duties

• Work in a small, cross-functional project team to design, develop and verify new concepts for advanced energy catheters and/or flexible electromechanical instruments and related accessories (e.g. medical cables)
• Develop, implement, test and document new solutions, processes, and designs according to corporate standards and departmental operating procedures Hands-on assembly and testing of devices to support proof of concept, design development, pre-clinical and V&V activities
• Investigate and determine root cause of emerging design or manufacturing defects/failures.

Development and documentation of design and manufacturing documentation including inspection procedures, assembly instructions, test methods, purchase specifications, BOMs, part and assembly drawings using appropriate change control procedures

• Collaborate with clinical engineering team to assess product concepts and do tradeoff analysis of proposed designs and feature sets
• Observe clinical cases and participate in interviews with clinical experts to inform designs; provide support for pre-clinical labs and clinical cases
• Establish individual goals consistent with overall project goals
• Performs other duties as required to support the company's overall strategy and goals

Qualifications

Required Skills and Experience

Typical minimum of 8 years of relevant experience, minimum

• 6 years with a masters
• Demonstrated ability to work in cross-functional research and development teams Experience with FDA QSR 21 CFR Part 820, ISO 13485, ISO 14971 and other related standards desired
• Proven track record operating in highly ambiguous environments with limited data, effectively identifying key risks and prioritizing experiments to accelerate learning Hands-on experience with rapid prototyping methods for flexible instruments and associated components, including 3D printing, plastics processing, metal fabrication, and bench-level assembly
• Proficiency in CAD-based mechanical design (SolidWorks preferred) Experience with part/mechanism design including 3D printing and plastic injection molding Experience in integrating fluid management features within flexible instruments (irrigation, perfusion, cooling, etc.) preferred.

Experience with all phases of the product development lifecycle; including proof-of-concept, design, implementation, debug, verification, qualification, and transfer High autonomy and ability to work independently under limited supervision to determine and develop approach to solutions. Ability to communicate effectively (written, oral) across all levels and organizations Required Education and Training Minimum education: BS or MS in Mechanical Engineering, Mechatronics, Biomedical Engineering or related engineering or scientific discipline, or equivalent work experience

Preferred Skills and Experience

Experience with flexible electromechanical device development is a strong plus Understanding of medical system integration and interfaces is a plus Experience with energy delivery devices is a plus Experience with IEC60601 impact on instrument/accessory design is a strong plus