Manufacturing Engineer 3

Intuitive•Sunnyvale, CA

About The Position

Join a team of Manufacturing Engineers pushing the frontiers of minimally invasive robotically assisted surgery by advancing production processes for Endoscope Instruments. Refine the process architecture for optimal reliability, quality, and cost. This Manufacturing Engineering role is responsible for developing lean manufacturing processes and the associated documentation.

Requirements

Excellent organizational skills; able to manage multiple fast-paced assignments simultaneously
Ability to communicate effectively and professionally across a range of technical disciplines with a broad slate of stakeholders, including management, peers, customers, and suppliers
B.S. degree in engineering discipline

Nice To Haves

3-5 years of experience in NPI, manufacturing, or design engineering is preferred
Engineering experience manufacturing, testing, and calibrating complex electro-mechanical products is preferred
Knowledge of a wide range of manufacturing processes, such as machining, injection molding, MIM, crimping, welding, testing of optical devices, and fiber routing is preferred
Strong quantitative process development skills in areas such as (p)FMEA, tolerance analysis, DoE, SPC, GR&R, and CpK is preferred
Experience with Mechanical CAD (Solidworks) and PLM (Agile) software is preferred
Prior experience with the Design Control processes for medical devices is preferred
Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment is preferred

Responsibilities

Contribute to a collaborative team, which is focused on continuous improvement
Employ Design for Manufacturing/Assembly (DFx) to develop optimal product architecture in terms of reliability, quality, and cost.
Specify, design, document, and procure the equipment necessary to perform each process step.
Plan, budget, and provide the production equipment necessary to meet manufacturing capacity requirements.
Define lean manufacturing process flows to maximize production efficiency.
Author process FMEA’s to identify and address potential manufacturing defects and minimize risks to patient safety.
Validate manufacturing equipment and processes to ensure efficacy and compliance with applicable requirements.
Maintain and improve production quality, yield, cost, and capacity.
Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition, and Engineering Change Order (ECO) implementation.
Provide technical support for failure analysis and root cause investigation of product failures.