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Quality Engineer 3 at Intuitive Surgical, Inc.

Posted in General Business 30+ days ago.

Type: Full-Time
Location: Sunnyvale, California





Job 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.

Intuitive Surgical

Surgical robotics was littlemore than a medical curiosity until 1999, the year Intuitive Surgicalintroduced the da Vinci® Surgical System. Today, Intuitive Surgical is theglobal leader in the rapidly emerging field of robotic-assisted minimallyinvasive surgery. Since its inception, the company has consistently providedsurgeons and hospitals with the tools needed to improve clinical outcomes andto help patients return to active and productive lives.

With its corporate headquarterslocated in Sunnyvale, California, Intuitive Surgical serves customersthroughout the United States and internationally, providing technology andprocedural innovation across cardiac, urology, gynecologic, pediatric andgeneral surgical disciplines.

Primary Function of Position:

As Intuitive's da Vinci® Surgical System becomes adopted by anincreasing population of hospitals, surgeons and patients, we are building afocused team to drive reliability, quality, and safety to ever-better levels.This focus applies to product in use, product in manufacturing, and product indesign. Help us powerfully drive our quality mission in our young and growingcompany by bringing your hands-on experience in solving tough engineeringproblems, your fascination with complex electro-mechanical devices, and yourpassion for the best practices to design, monitor, and improve productand process. Intuitive seeks a strong technical contributor who can help definepractical, useful quality metrics and specifications, identify keyopportunities for product improvement, launch quality initiatives, leadprojects to implement these initiatives, and serve as an expert consultant tohelp solve the most technically challenging quality problems. The idealcandidate possesses a broad base of experience and a high level of technicaldepth in at least two technical specialties applicable to medical robotics, andis equally at home in the test lab and providing technical leadership to ourteam as we develop standard practices of our organization. You will not abide"process red tape", instead passionately seeking the most efficient way tobuild in product quality. And you will also coach, mentor, teach, and influencethe engineering staff in best quality practices, data analysis, protocoldevelopment, and design for quality and reliability methods.

Roles and Responsibilities:

This position has responsibility for:

30% involvement in new product development, 40% production linesupport and failure investigation, 30% quality advocacy and project management.


  • Quality Advocacyand Project Management


    • Develop and applycorporate level quality metrics.

    • Lead and projectmanage quality initiatives in one or more of these focus areas:


ProductQuality

Data Quality

ProcessQuality


  • ProductDevelopment


    • Handle projectsof various product and subsystem types (Software, Mechanical Hardware, Camera, Disposableaccessories like catheter, etc).

    • Supportestablishment and qualification of repair/service lines for field replaceableunits from new product platforms.

    • Ensure that theessential performance aspects are inspected for as part of repair test process.

    • Provide guidanceto other engineers regarding applicable regulatory and statutory requirementsand the applicability of these requirements to the ISI products.

    • Ensure processcompliance through the design and development of comprehensive proceduresincluding work instructions, flowcharts, forms, templates, checklists, andother product or process related documentation, for recording, evaluating, andreporting quality data.

    • Support analysisand disposition of discrepant material.

    • Supportmanufacturing/repair process changes, including: review and approval of changeorders (ECO's), reviewing tooling qualifications, and proactively ensuringrepair processes stay aligned with any new changes introduced in new productmanufacturing

    • Development ofMaster Validation Plans for new facilities and products which include theidentification of components and processes that require specific attention toassure the quality of the over-all products and the methods for applying thatattention including the generation and/or oversight of the following:


      • Applicable DOPs and SOPs

      • Design Risk: FMEA, design V&V

      • Process Risk: Process FMEA, Supplier Process FMEA,in-house Process V&V, supplier process V&V, EFT Qualifications, Linequalifications

      • Generation of Quality Assurance processes forforward production including drawing reviews, incoming inspection plans,Quality Assurance Plans (QAPs), and Final Quality Inspection (FQI) procedures.


    • Supportdevelopment and execution of process validation protocols and reports


  • Operations/ProductionSupport and Failure Investigation


    • Monitorsmanufacturing procedures, processes and records for compliance with establishedrequirements.

    • Reviews andtrends product and process quality issues using data analysis.

    • Evaluatesdeviations, non-conformances and supports resolution of quality issues.

    • Responds toquality escalations and provides technical support for troubleshooting, repair,testing and supports root cause investigation along with design/manufacturingengineering.

    • Performs riskanalysis, product impact assessment and determines disposition fornon-conformances.

    • Escalates tomanagement all quality issues that could impact patient safety or surgicalefficacy.

    • Ensures andsupports on-time completion of department projects, communicates constraints todirect management when successful completion is at risk.

    • Review and/orrelease process and document changes through engineering change orders anddeviations using ISI change control process.

    • Review andinterpret complex data analysis rooted in an understanding of our producthardware and software, the physics of failure, and the use conditions in theclinical / operating room environment.


Skill/Job Requirements:

Competency Requirements: In order to adequately perform theresponsibilities of this position the individual must possess:


  • Education: Bachelordegree in electrical, mechanical or system engineering, math, or physics.Advanced degree preferred.

  • Minimum 5+years of working experience in Quality Engineering, minimum 3 years in medicaldevice design or manufacturing environment.

  • Able to navigatequality and compliance system with minimal oversight on individual projects.

  • Demonstrated understandingof CFR 21 820/ ISO 13485 requirements for making process or design changes.

  • Understands productrisk management, experience in generating FMEA and process FMEA.

  • UnderstandsDesign Controls, Change Controls, Product and Engineering Processes.

  • Proficient with generatingand executing Qualification and Validation protocol and Quality AssuranceProcedures.

  • Experienced inleading product containment and rework activities.

  • Proficient in SPC& Six Sigma methodology and tools (e.g. uses DMAIC process and basic toolssuch as 5 Why's, control charts, fishbone diagram).

  • Understandstypical Excel data analysis operations (e.g. Vlookup, Pivot table and pivotchart functions). Able to create Multi-source report, trends, and interpretsdata with minimal oversight.

  • Capable ofthinking independently and makes decision based on limited information.

  • Capable of initiatingimprovement discussion and leads the team toward the goal.

  • Can presentinformation in various forms and forums, collaborates with peers across functions.Experience in presenting to cross functional mgmt. communications. (e.g. report writing, presentations, QRBpresenter).

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.





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