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Staff Manufacturing Engineer

Job Description

Job: Manufacturing & Operations
Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Schedule: Full-time
Requisition ID: 200489

Description

Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and
decreasing surgical invasiveness, with patient safety as our highest priority.

Primary Function of Position:

This highly skilled manufacturing engineer will own multiple manufacturing lines for both mature and new products. In addition to individual line ownership, the ideal candidate must be able to act as a technical leader to other teammates, assuming shared ownership of multiple manufacturing lines and projects. This key technical leader will guide and mentor a talented product development and manufacturing organization in specifying and refining bills of materials (BOMs), work flow processes, assembly tooling design, and detailed assembly/test instructions while optimizing reliability, efficiency, capacity, cost, and safety.

Roles and Responsibilities:

• Provide technical leadership for Ion Instruments Manufacturing organization
• Support the Ion Vision Probe line as an individual contributor, while providing leadership to other teammates regarding their manufacturing lines, must be able to:
o Establish regular communication with the production team to ensure they have the best support possible for both short and long term needs
o Manage product reliability improvements from concept to implementation
o Identify, design, qualify, document and introduce assembly/test fixtures and equipment
o Improve manufacturing process flows of Ion instrument manufacturing lines to optimize for reliability, efficiency, capacity, cost, and technician safety
o Execute and mentor others in manufacturing process validations, process FMEAs, and other elements associated with production Master Validation Plans.
o Provide product and process Design for Manufacturing/Assembly (DFX) input to enhance manufacturability and lead improvement implementations
o Manage manufacturing strategy and production capability for Ion Instrument lines to minimize customer backorders.
o Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition and Engineering Change Order (ECO) implementation
o Provide technical support for failure analysis and root cause investigation of product failures, especially on vision-related parts and processes.
• Establish group objectives and individual work goals consistent with overall product development goals:
o Assign tasks, set priorities, establish metrics and track progress
o Assess employee performance and provide coaching to improve performance
• Manage and allocate team resources over multiple projects. Provide and solicit resources to and from other teams as necessary
• Provide budget estimates for product, process improvements, and prototype materials, tooling and testing
• Work with Quality and Regulatory teams to ensure that the team follows appropriate GMP, design history file (DHF), and device history record (DHR) guidelines per FDA requirements.


Qualifications

Skill/Job Requirements: 

• B.S. degree in engineering discipline, M.S. preferred
• Prior responsibility for validation/verification of processes, equipment and products
• Strong technical analytical skills including background with vision-related products
• Prior responsibility in decision making for component manufacturing processes (machining , injection molding & MIM, stamping, coining, extrusion)
• Familiar with mechanical CAD software (SolidWorks)
• Good organizational skills. Ability to work on several fast-paced projects simultaneously.
• Prior experience with managing product, process changes
• Mechanical design and analysis skills, including statics, dynamics, kinematics, strength of materials, and stress analysis is a plus
• Ability to motivate, guide, and inspire members of the core and extended project team (technicians, purchasing, planning, engineering, regulatory, quality)
• Able to communicate effectively and professionally with customer, suppliers, and other people outside the company
• Prior experience with Design Control processes for medical devices and/or clinical applications of the surgical instruments, and/or automated equipment design is a plus
• Experienced in ISO 13485, ISO 9001, or medical device manufacturing environment, Six Sigma is a plus


We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.