Quality Engineer 2 - Multiport Da Vinci (Sustaining)

Intuitive Surgical•Peachtree Corners, GA

43d

About The Position

As Intuitive' s da Vinci Surgical System becomes adopted by an increasing population of hospitals, surgeons and patients, we are building a focused team to drive reliability, quality, and safety to ever-better levels. This focus applies to product in use, product in manufacturing, and product in design. Help us powerfully drive our quality mission in our young and growing company by bringing your hands-on experience in solving tough engineering problems, your fascination with complex electro-mechanical devices, and your passion for the best practices to design, monitor, and improve product and process. The position is a quality engineer-2 based out of Peachtree corners, GA and will support manufacturing and remanufacturing of systems for the Davinci Multiport business unit.

Requirements

2+ years of relevant experience in medical device or manufacturing environment.
Understanding of CFR 21 820/ ISO 13485 requirements for making process or design changes.
Understands product risk management, experience in generate FMEA and process FMEA.
Understands Design Controls, Change Controls, Product, and Engineering Processes.
Experienced in leading product containment and rework activities.
Proficient in SPC & Six Sigma methodology and tools (e.g. uses DMAIC process and basic tools such as 5 Why's, control charts, fishbone diagram).
Understands typical Excel data analysis operations (e.g. Vlookup, Pivot table and pivot chart functions) Able to create Multi-source report, trends, and interprets data with minimal oversight.
Ability to communicate effectively both verbally and in writing Integrity: Accepting and adhering to high ethical, moral, and personal dealing with others values in decisions, communications, actions, and when Dealing with others
Ability to work independently and handle tasks with competing priorities effectively.
Education: Bachelor's degree in electrical, mechanical or system engineering, math, or physics.

Nice To Haves

Advanced degree preferred.

Responsibilities

Support manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, and defect containments.
Support development and execution of process validation and verification test plans, protocols, and reports.
Support production ramp and work cross functionally on issue and support continuous improvement projects.
Support investigation and disposition of non-conformances, both internal and supplier related.
Assist in executing design verification & validation efforts by working with cross functional teams.
Contribute in risk management process ensuring that the essential performance aspects are correctly mitigated in the product quality plans.
Ensure design changes are established and implemented according to ISI standards and applicable regulations.
Recommend design processes and methods to meet quality goals (DFX, etc.).
Develop and apply corporate-level quality metrics.
Ensure the quality system requirements are effectively established and maintained.
Lead and manage quality initiatives in one or more areas of product and processes quality.
Evaluates deviations and non-conformances and supports resolution of quality issues
Supports process validation and verification.
Perform risk analysis and determines quality disposition for variance requests and non-conformances
Releases process and document changes through engineering change orders and deviations using ISI change control process
Ensures successful, on-time completion of department projects, communicates constraints to direct management when successful project completion is at risk
Performs other duties as assigned by the management.