Component Engineer 4

Primary Function of Position:
Responsible for ensuring suppliers meet ISI requirements for cost, quality, delivery and
service. Drive suppliers to continuously improve business and manufacturing processes.
Evaluate and select suppliers. Guide R&D 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.

Roles & Responsibilities:
• Select, evaluate, and qualify suppliers
• Part qualification including pFMEAs, FAIRS, Cpk, and Control Plans
• Supplier Corrective Action Request initiation, execution, and closure
• Ensure compliance to quality management system and regulatory requirements
by leading and mentoring auditors for QMS audits
• Lead detailed projects of transfers of the supply of products and components
• Create strategies to effectively optimize the supply base by leading efforts to
optimize supply networks.
• Drive suppliers to continually improve their business and manufacturing process
performance to meet Intuitive Surgical’s requirements for supplier excellence
including ship to stock programs using a collection of best practices in project management, Six Sigma, Lean, SPC and negotiation by leading these efforts without managerial guidance at several suppliers simultaneously.
• Develop and influence using metrics for supplier part cost, delivery, quality,
capacity and capability by creating metrics to measure real improvement and
judge required intervention or change at the supplier or in a commodity.
• Drive corrective actions for supplier process by driving suppliers to true root
cause analysis and corrective and Preventive actions.
• Drive changes to ISI specifications through influencing and educating resulting in
changing specifications and drawings including driving the ECO process to
implementation.
• Provide effective and timely supply base health information to management by
creating and delivering data-driven supply base information to any level of
management at ISI with little or no guidance (including QRB) and provide
recommendations.
• Prepare and deliver supplier communications as required by independently
working with suppliers on scorecard creation of QBRs, Supplier Summits, etc.
• Facilitate supplier contract development to execution and maintenance by
negotiating contracts as necessary in collaboration with the contract team and
Supply Chain Management.
• Manage the ASL and Global Commodity Matrix
• 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.
• 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 preferred
suppliers.

• Deliver the following Quality deliverables: pFMEA, Special
Process Validations, FAI, and Cpk by leading, training and mentoring suppliers
through the pFMEA development, judging process validation requirements and
signing-off on protocols as ISI rep, judging process capability with supplier as
well as judging FAI suitability.
• Develop the supplier business continuity / disaster recovery plans by managing
suppliers to create plans, judge plans for risks and negotiate with suppliers to
reduce risks. Identify and investigate opportunities for cost reduction and/or
quality improvement by judging opportunities and creating strategies to seize
those opportunities, completes research and provides data-driven plans to
management.
• Review, analyze and close customer complaints, manufacturing variance
requests, and first article inspections by judging risk analyses and justifications,
determining corrective and preventive actions at suppliers, looks for opportunities
with suppliers to eliminate recurrence

Qualifications

Skills, Experience, Education, & Training:
• BS degree in Engineering or equivalent, experience in machining commodity
preferred
• Minimum 10 years related experience in Supplier
Engineering/Development/Quality or related field
• Excellent written and verbal communication skills including presentations to
executive level management
• Excellent Interpersonal skills and team building skills
• 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 (experience in auditing
suppliers to these standards)
• Significant computer experience using Windows, Word, Excel, Access and ERP
Information Systems, preferably SAP
• CAD experience with 3D modeling tools 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 and communicate
technical information
• Ability to travel to suppliers on an as needed basis – domestic and international

Additional Information

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.

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.