Component Engineer

Intuitive; Sunnyvale (CA); Presencial; USD 137.000 - 161.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Market-competitive compensation

Equity

Descripción de la vacante

Intuitive Surgical in Sunnyvale, CA is seeking a senior supplier engineer to ensure supplier compliance with cost, quality, delivery, and service requirements. You will drive supplier performance, lead audits, and guide R&D in supplier selection for new products, while improving manufacturing processes and DFM inputs.

The role requires extensive experience in supplier development, quality systems, and cross-functional collaboration with engineering and procurement.

Formación

• BS degree in Engineering or equivalent, machining experience 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 and team-building skills.
• Proven history of implementing Lean/6 Sigma/SPC programs at suppliers.
• Strong analytical and problem-solving abilities with good judgment.
• Knowledge of evaluating supplier capabilities and manufacturing processes.
• Understanding of 21 CFR part 820 and ISO 13485; auditing suppliers.

Responsabilidades

• Select, evaluate, and qualify suppliers.
• Lead supplier quality assurance and corrective actions.
• Ensure QMS and regulatory compliance; mentor auditors.
• Drive supplier performance improvement and cost reductions.
• Manage supplier communication, scorecards, and supplier summits.
• Develop and influence supplier cost, delivery, quality, capacity metrics.
• Lead ISI ECO changes and supplier-related documentation.
• Collaborate with ISI engineering on new product introductions using DFM inputs.

Conocimientos

Communication skills

Analytical thinking

Problem solving

Team collaboration

Lean/Six Sigma

Educación

BS degree in Engineering or equivalent

Herramientas

SAP ERP

CAD tools

MS Office

Descripción del empleo

• Ways of Working: Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.
• Employee Type: Employee
• Min. Salary Region 1: 160600 USD
• Global Job Level (HCM): Professional 4 (11)
• Min. Salary Region 2: 136500 USD

Company 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.

Job Description

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.

• 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 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.

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 employeeswho 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’sstart 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
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.

Accommodation & Accessibility Notice:

Intuitive is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require assistance or an accommodation during any part of the application or interview process, please contact People Services at [e-mail].

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.