Sr Supplier Manufacturing Engineer, Machining

Intuitive Surgical Inc

  • Sunnyvale, CA
  • 3 days ago
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    Skills

    • 3D Modelingunmatched
    • Agile Programming Methodologiesunmatched
    • Analysis Skillsunmatched
    • Best Practicesunmatched
    • Biomedicineunmatched
    • Business Processesunmatched
    • CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing)unmatched
    • Change Managementunmatched
    • Code of Federal Regulationsunmatched
    • Communication Skillsunmatched
    • Compression Moldingunmatched
    • Computer Skillsunmatched
    • Continuous Improvementunmatched
    • Contract Manufacturingunmatched
    • Corrective Actionunmatched
    • Corrective and Preventative Action (CAPA) Systemsunmatched
    • Cost Controlunmatched
    • Documentationunmatched
    • ERP (Enterprise Resource Planning)unmatched
    • Electronicsunmatched
    • Engineering Change Managementunmatched
    • Engineering Change Orderunmatched
    • Establish Prioritiesunmatched
    • Geometric Dimensioning and Tolerancingunmatched
    • Governmentunmatched
    • Healthcareunmatched
    • ISO (International Organization for Standardization)unmatched
    • Import/Exportunmatched
    • Information Technology & Information Systemsunmatched
    • Injection Moldingunmatched
    • Interpersonal Skillsunmatched
    • Lean Six Sigmaunmatched
    • Licensingunmatched
    • Machiningunmatched
    • Manufacturingunmatched
    • Manufacturing Analysisunmatched
    • Manufacturing Engineeringunmatched
    • Manufacturing/Industrial Processesunmatched
    • Mechanical Engineeringunmatched
    • Medical Equipmentunmatched
    • Metal Manufacturingunmatched
    • Metal Moldingunmatched
    • Metricsunmatched
    • Microsoft Access Databaseunmatched
    • Microsoft Excelunmatched
    • Microsoft Windows Operating Systemunmatched
    • Microsoft Wordunmatched
    • Minitabunmatched
    • Molding Processesunmatched
    • Multitaskingunmatched
    • Negotiation Skillsunmatched
    • Performance Managementunmatched
    • Plastic Injection Moldingunmatched
    • Plastics Manufacturingunmatched
    • Polymersunmatched
    • Presentation/Verbal Skillsunmatched
    • Problem Solving Skillsunmatched
    • Process Analysisunmatched
    • Process Capabilityunmatched
    • Process Failure Mode and Effects Analysis (PFMEA)unmatched
    • Process Improvementunmatched
    • Process Validationunmatched
    • Product Developmentunmatched
    • Product/Service Launchunmatched
    • Production Controlunmatched
    • Project/Program Managementunmatched
    • Protocol Independent Multicast (PIM)unmatched
    • Purchasing/Procurementunmatched
    • Quality Managementunmatched
    • Requirements Managementunmatched
    • Riskunmatched
    • Risk Analysisunmatched
    • Risk Managementunmatched
    • Root Cause Analysisunmatched
    • SAPunmatched
    • SolidWorksunmatched
    • Statistical Analysis System (SAS)unmatched
    • Statistics Softwareunmatched
    • Supply Chainunmatched
    • TCP (Transmission Control Protocol)unmatched
    • Team Lead/Managerunmatched
    • Technical/Engineering Designunmatched
    • Time Managementunmatched
    • Total Cost of Ownershipunmatched
    • Training/Teachingunmatched
    • Vendor/Supplier Evaluationunmatched
    • Vendor/Supplier Managementunmatched
    • Vendor/Supplier Planningunmatched
    • Vendor/Supplier Relationsunmatched
    • Vendor/Supplier Selectionunmatched
    • Vendor/Supplier Sourcingunmatched
    • Willing to Travelunmatched
    • Writing Skillsunmatched

    Description

    It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies-like the da Vinci surgical system and Ion-have transformed how care is delivered for millions of patients worldwide.

    We're a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

    The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful-because every improvement we make has the potential to change a life.

    If you're ready to contribute to something bigger than yourself and help transform the future of healthcare, you'll find your purpose here.

    Primary Function of Position

    Responsible for ensuring suppliers meet ISI requirements for quality, service, delivery, and cost. Drive suppliers to continuously improve business and manufacturing processes. Evaluate and select suppliers. Guide Engineering in choosing suppliers for new products and provide DFM input to new designs. Supports both NPI and on-going production, monitors and works with suppliers to improve supplier performance. Executes detailed projects with suppliers to implement changes and improvements affecting quality, cost, capacity, risk, and sub-supplier management.

    The ideal Candidate possesses broad and deep hands-on metal injection molding (MIM), plastic injection molding (PIM), and/or machining experience along with skills to select and develop suppliers. The scale and impact this candidate will have on Intuitive's core business and products is very high. Self-motivated and driven candidates are encouraged to apply.

    Essential Job Duties

    • Complete project/ part qualification deliverables including Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability Analysis
    • Work with suppliers to execute cost reductions, capacity improvements, and supply chain risk mitigation efforts like dual sourcing or supplier driven design improvements.
    • Select the right process and supplier for the part, considering long term fit and total cost of ownership
    • Manage supplier changes including manufacturing process changes, production optimization, facility changes, new equipment qualification, and new line validations
    • Drive changes to ISI requirements as necessary by initiating and managing changes to specifications and drawings through the engineering change order process
    • Own and drive to closure supplier variances from symptom through root cause analysis to corrective action, including careful CAPA documentation
    • Effectively prioritize and advance multiple concurrent projects and tasks
    • Clearly communicate project status to key stakeholders
    • Build, own, and relentlessly pursue a vision for developing suppliers
    • Understand proper level of documentation detail for tracking of actions and justification of decisions
    • Generate key metrics for the team and suppliers, and continually drive for timely achievement of those metrics
    • Drive suppliers to continually improve their business and manufacturing process performance to meet Intuitive's requirements for supplier excellence using a collection of best practices in project management, Six Sigma, Lean, SPC and negotiation. Lead these efforts without managerial guidance at several suppliers simultaneously
    • Implement corrective and preventive actions for supplier process by driving supplier's investigations and root cause analysis, reduce issue recurrence through thorough RCA implementation.
    • DFM by engaging suppliers early in development cycle to feedback manufacturability improvements in the designs prior to production
    • Influence and guide Engineering in choosing suppliers by determining selection criteria for preferred suppliers and leading the team effort to evaluate & build preferred suppliers
    • Review, analyze and close customer complaints, manufacturing variance requests, and first article inspections by judging risk analyses and justifications
    • Work with suppliers and ISI engineering for the new product introduction to:
    • Create product supplier landscapes to determine launch readiness and report to management
    • Develop supplier ramp readiness plans by judging business risk based on forecast, supplier capacity, quality performance, and process capability.
    • Collaborate with Supply Chain & purchasing organizations to ensure new suppliers meet financial and viability thresholds to onboard onto Intuitive Approved Supplier List.

    Required Skills and Experience

    • Minimum 8 years related experience in engineering and manufacturing of metal injection molding (MIM), plastic injection molding(PIM), and/or Machining. Hands on plastic injection molding experience is highly desirable, including but not limited to Scientific Injection Molding (SIM) principles, plastic DFM, Silicone molding (LSR and/or compression molding).
    • Excellent written and verbal communication skills including presentations to executive level management and technical SMEs within Design Engineering, Manufacturing Engineering, & Supplier Engineering
    • Excellent Interpersonal skills and team building skills. Ability to build and foster great working relationships with external suppliers is invaluable.
    • A proven history of implementing Lean/6 Sigma/SPC Programs at suppliers
    • Excellent Project Management skills
    • Excellent analytical and problem solving skills along with good judgment
    • Demonstrable knowledge in evaluating and challenging supplier technical, quality, and business capabilities
    • Demonstrable knowledge of a wide range of manufacturing processes including understanding of key input variables for quality, cost, and capacity (specialization can be in metal fabrication, plastics, electronics, and/or contract manufacturing)
    • Excellent knowledge of 21 CFR part 820 and ISO 13485
    • Significant computer experience using Windows, Word, Excel, Project, Access, and ERP Information Systems, preferably SAP or Agile
    • CAD experience with 3D modeling tools is a plus, such as SolidWorks
    • Experience with statistical analysis software such as Minitab is a plus
    • Proven ability to motivate suppliers
    • Experience in a high-volume medical device company is a plus
    • Ability to read and interpret detailed mechanical drawings (GD&T) and communicate technical information
    • Ability to travel to suppliers on an as needed basis - domestic and international

    Required Education and Training

    • BS degree in Engineering (Mechanical, Industrial, Manufacturing, Biomedical, Polymer Science etc.) or equivalent experience. Advanced degree preferred.

    Working Conditions

    • Ability to travel to suppliers on an as-needed basis - domestic and international

    Preferred Skills and Experience

    • New product development experience is a plus

    Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

    Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

    Mandatory Notices

    U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees
who are nationals from countries currently on embargo or sanctions status.

    Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process).

    For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee's
start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.

    We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

    Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

    This position may be filled at a different job level than listed here depending on

    business need and/or on the selected candidate's experience, knowledge and skills.

    Compensation will be based primarily on the job level at which the role is filled and the

    candidate's qualifications, consistent with applicable law.

    We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.

    Numbers & Facts

    LocationSunnyvale, CA

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