Manager, Mechanical Engineering, NPD Systems

Intuitive•Sunnyvale, CA

About The Position

The Ion™ endoluminal system is Intuitive's robotic platform for minimally invasive biopsy in the peripheral lung, with an initial goal of improving the early diagnosis of lung cancer. Our New Product Development (NPD) team is seeking a candidate with an analytical mind and exceptional design skills to be a technical leader and guide their team through technical challenges while committing to the highest product quality for our robotic platform. The ideal candidate will thrive in a high-energy, focused, small-team environment and be comfortable handling multiple priorities. This role is an exciting opportunity to join a rapidly growing new business within Intuitive and contribute meaningfully to its future growth.

Requirements

Excellent technical judgment in the presence of competing priorities and incomplete data to drive schedule decisions; proven ability to make difficult trade-offs.
Ability to lead, collaborate, and motivate across functional boundaries with multi-disciplinary teams like clinical, quality, regulatory, manufacturing, etc.
Experience in designing with a focus on robotics and/or medical products.
Hands-on technical leadership of a team of mechanical engineer responsible for product development in a relevant domain.
Experience defining ambiguous requirements with user-facing teams.
Strong analytical skills as proven by a track record for analyzing and fixing complex problems in products and processes.
Passion for solving tough technical problems and creating elegant and reliable products.
Determination to execute the vital thing, efficiently and well; attention to the right details.
Self-driven desire to excel in a high-energy, small, focused team environment, to maintain a strong sense of shared responsibility and shared reward, making work interesting, meaningful, and enjoyable.
Expertise in communicating effectively and accurately (written and oral) across all levels and functions, including interacting with suppliers, and presenting to a technical audience.
Master’s degree in mechanical engineering or related field, or equivalent work experience, 4+ years’ experience (or Bachelor’s with 6+ years’ experience)

Nice To Haves

Training or commensurate experience in Root Cause Analysis.
Experience in a regulated environment (FDA, Military, FAA or equivalent).
Comfortable with execution of design verification/validation test protocols, assessing risk (FMEA), providing inputs to regulatory agency approval including UL, CE and FDA is a plus.
Proven ability to lead teams and manage stakeholders.

Responsibilities

Understand and exemplify Intuitive’s culture of first principles thinking and that patients come first, always.
Establish and enforce design standards, drawing conventions, and engineering review processes within the team. Guide them through FEA, tolerance analysis, and implementing design-for-manufacturing (DFM) methodologies.
Review and approve engineering documentation including specifications, BOMs, test plans, and validation reports.
Coach, evaluate and give feedback to the team members throughout the year and through annual Performance Review.
Work with team members to create long-term development plans.
Manage the team’s assignments, priorities and budget annually.
Provide guidance through complex situations or conflicting goals.
Oversee and approve mechanical design activities across all phases of NPD, from concept through production release and stabilization, ensuring designs meet the highest level of performance, safety, and manufacturability requirements.
Lead or facilitate design reviews and ensure corrective actions are tracked and resolved.
Ensure team compliance with applicable regulatory and industry standards (e.g., ISO, ASTM, FDA if applicable).
Identify and proactively mitigate technical risks within the mechanical design domain throughout the product development lifecycle.