Manufacturing Engineer

Intuitive•Sunnyvale, CA

18h

About The Position

Contribute your technical manufacturing, equipment design and project management skills to a dynamic manufacturing engineering team creating precision instruments for minimally invasive robotic surgery. The role requires active participation in a manufacturing engineering organization in order to refine electro-mechanical components, assemblies, process documentation, tooling and test methods to improve efficacy, reliability, manufacturability and cost for surgical robotic instruments.

Requirements

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

Nice To Haves

M.S. degree in engineering discipline preferred
1-3 years of experience in NPI, manufacturing, or design engineering supporting Mid-high volume complex mechanism manufacturing experience
Knowledge of a wide range of manufacturing processes, such as machining, injection molding, MIM, crimping, welding, soldering, or joining with adhesives
Quantitative process development skills in areas such as (p)FMEA, tolerance analysis, DoE, SPC, GR&R, and CpK
Experience with Mechanical CAD (Solidworks) and PLM (Agile) software
Prior experience with the Design Control processes for medical devices
Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment

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.
Evaluate and help in the selection of suppliers for mechanical parts if required.
Help resolve supplier quality issues.
Update and revise Manufacturing Process Instructions (MPIs) to ensure accuracy and completeness
Address line support issues as they arise; Document and report any variances, problems, issues, or concerns on all aspects of the manufacturing process
Provide production personnel with expectations and performance feedback regularly in the production process
Understand, train personnel, and enforce strict adherence to the applicable Department Operating Procedures (DOPs) and Standard Operating Procedures (SOPs) of the Quality System
Maintain up-to-date and accessible training records for MPIs and Quality System documents
Assist in setting and attaining quarterly and annual production goals
Learn and enforce company safety policies and practices
Active participant in quality improvement initiatives, providing feedback to find the root cause and problem-solving.