Manufacturing Engineer

Intuitive•Sunnyvale, CA

36d

About The Position

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.We're a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.If you're ready to contribute to something bigger than yourself and help transform the future of healthcare, you'll find your purpose here.Primary Function of PositionThis role manages advanced manufacturing engineering projects, process validation and optimization, and compliance with medical device regulations for production scale-up and improvement.

Requirements

Minimum 3 years of experience in manufacturing engineering or relevant discipline and a bachelor's degree, or equivalent combination of education and experience
Proficient in manufacturing process design, validation, data analysis, and troubleshooting.
In-depth knowledge of FDA, ISO 13485, and GMP requirements.
Strong leadership, technical writing, and project management skills.
Experience with Lean, Six Sigma, or similar methodologies.
Ability to lead cross-functional problem-solving teams.
Office and manufacturing floor presence.
Occasional lifting of equipment, components (up to 15 lbs).
Extended standing, walking, and occasional travel.

Responsibilities

Lead process improvement and optimization projects for manufacturing lines.
Design and validate manufacturing processes and equipment per regulatory standards.
Analyze production data to identify and address performance gaps or inefficiencies.
Develop and execute equipment validations, IQ/OQ/PQ protocols.
Investigate and resolve process and equipment failures.
Manage change control and update technical documentation (SOPs, WI, BOMs).
Support new product introduction and transfer to manufacturing.
Mentor and train junior engineers and production staff.
Participate in regulatory audits and ensure compliance with FDA, ISO 13485.
Drive continuous improvement and cost reduction initiatives.