Manager – Mechanical Engineering

Job Description

Primary Function of Position

The Manager Mechanical Engineering, Advanced Energy, is responsible for leading the technical development of advanced energy products at Intuitive. Their focus will be on the electromechanical design of advanced energy catheters and instruments, contributing to the exploration of novel system concepts for new applications of surgical robotics. The Manager Mechanical Engineering will have a direct role in the design and oversight of a new product portfolio based on advanced energy modalities, helping develop a cross-functional team to take the technology from benchtop to bedside. They will create and lead a Design Engineering team from an early phase and support innovative technology development and commercialization. They will manage scope, schedule, and budget for the technical development of novel advanced energy technologies. They will be hands-on and have both the technical depth to resolve complex mechanical, electrical, material, design, and manufacturing issues as well as the ability to work in an interdisciplinary team to troubleshoot and root cause higher-level system issues. They must have exceptional technical depth in relevant areas and have a track record of successful team building and 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 be committed to high-quality prototypes and concepts. An exceptional sense of shared responsibility and shared reward is required, as is a commitment to high product quality.

Essential Job Duties

• Lead a cross-disciplinary design team as a technical lead and engineering manager to develop and verify new concepts for advanced energy instruments and other flexible electromechanical instruments
• Lead and manage requirements generation/modelling; experience in requirement writing, translation, decomposition, management systems, tracing, HOQ/QFD, etc
• Develop and maintain system architecture, boundary diagrams, use conditions etc
• Lead risks identification and mitigation strategy per ISO14971 using tools such as HA and FMEA.
• Lead and manage a system-level technical risk register, including associated burn-down strategy and risk tracing
• Work closely with the test engineering teams to determine and develop the best methods to satisfy and verify design requirements and ensure design outputs are correctly assessed.
• Communicate to senior leadership the technical progress, health of development activities, program risks/mitigations, and key milestones
• Selects, develops, and evaluates personnel for technical team growth and development while mentoring junior engineers
• Support the quality and regulatory processes as required
• Landscape and generate valuable intellectual property
• Understands business environment and relates extensive knowledge of internal and external technological activities to trends in medicine and surgery
• Engage in pre-clinical (ex-vivo, in-vivo) and clinical cases and participate in interviews with clinical experts to inform design
• Create Design History File documentation as required by the company’s quality system and applicable regulations (FDA, MDR, etc)

OTHER

• Contribute to clinical scientific discussions with external stakeholders
• Keeps the organization’s vision and values at the forefront of decision-making and action
• Performs other duties as required to support the company's overall strategy and goals

Qualifications

Required Skills and Experience

• Comfortable with all phases of the product development lifecycle, including needs finding, defining solution space, proof-of-concept, design development, optimization, verification, and design transfer.
• Exceptional experience with FDA QSR 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601, and other related external standards
• Exceptional understanding of component design principles, design for reliability, and manufacturability as it relates to instruments, catheters, and/or end effectors.
• Contribute to design documentation for test protocols, results, reports, and complete tracing for requirements.
• Proficiency using CAD to design and document mechanisms; SolidWorks preferred. Experience with GD&T and other related ASME/ISO drafting standards
• Hands-on engineering experience with the proven ability to work well in a cross-disciplinary team environment
• Experience with program management, such as developing program strategy, schedules, risk registers, resource plans, and design development planning.
• Excellent communication skills and interpersonal/team effectiveness
• Exceptional influence and management skills; ability to build relationships and work cooperatively at all levels in the business and across business units

Required Education and Training

• Minimum education: BS or MS in Mechanical Engineering, Electrical Engineering, or related engineering or scientific discipline, or equivalent work experience
• Typical minimum 8 years of development experience in a regulated environment, including 1-3 years of people management (Advanced Degree Preferred)
• Minimum of 2yrs of electromechanical design and 4yrs of medical device development experience
• High autonomy and ability to work autonomously under limited supervision to determine and develop an approach to solutions.

Preferred Skills and Experience

• Device development experience on energy-based surgical or therapeutic products preferred
• Proven business acumen with entrepreneurial experience a plus

Working Conditions

Must be available to work full-time and commute/relocate to Sunnyvale, CA

• Up to 10% travel. Some international travel may be required.
• Primary Location: Sunnyvale, CA