Clinical Engineering Director Jobs in San Ramon, CA

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:
Provide leadership as well as technical, quality and administrative mentoring across interdepartmental boundaries to effectively develop suppliers providing components for robotic surgical equipment. This key Director role will be challenged to lead the Supplier Engineering resources as required to support business growth and sales demand. Proven experience achieving results through others and managing a broad range of individuals is required. Track record in medium to large-scale medical device manufacturing is preferable.
Roles & Responsibilities:

• Develop and maintain a Supplier Engineering and Development program.
• Build, own and relentlessly pursue a vision for developing suppliers
• Own and drive to closure supplier variances from symptom through root cause analysis to corrective action, including careful CAPA documentation
• Select suppliers with appropriate processes to ensure high quality and repeatability
• Drive supplier process improvements including but not limited to the following programs: 6 Sigma, SPC, and other statistical techniques, supplier certification and rationalization, and Lean Manufacturing Techniques
• Develop metrics that measure supplier performance and program effectiveness, and manages program of continuous improvement to drive these metrics
• Reach across the multiple organizations to identify opportunities for supplier development that benefit Intuitive Surgical's core goals
• Support Project Management and Commodity Team functions
• Build department function through training, coaching and recruiting
• Develop staff skills in project management and statistical process control to grow staff who are capable of addressing difficult problems, apply good judgment, exhibit ownership, and deliver quality work, on time and based on sound science
• Develop staff skills in auditing suppliers for compliance with supplier agreements and ensuring that agreements are being met
• Facilitate, influence and work cross-functionally to improve supplier processes with the following:
  • NPD, NPI and Quality Engineering groups in support of Early Supplier Involvement regarding all new products; reaches into early NPD stages to provide guidance on component selection; assists in design for manufacturing analysis; supports Intuitive design control
  • Corporate Purchasing group in support of supplier consolidation, cost reduction programs and Commodity Teams
  • Regulatory and Compliance groups in support of CAPA programs and SCAR resolution
  • Product Quality Assurance (Systems) and Clinical Engineering groups regarding component and product functional compliance
• Support the Supplier Quality department in holding responsibility for all aspects of regulatory compliance for suppliers, within the broader scope of Intuitive's Quality System
  • Manage Supply Base to full compliance, including all relevant guidance and regulations
  • Manage Supplier Engineering Function to full compliance
• Employ proven attention to detail and excellent process to ensure success
• Understand proper level of documentation detail for tracking of actions and justification of decisions
• Direct staff to generate daily, weekly, and monthly reports regarding supplier performance; direct supplier corrective actions from VR generation to IQC; support data complaint review data mining, interpretation, and presentation for Quarterly Management reviews
• Generate key metrics for the team and suppliers and continually drive for timely achievement of those metrics.

Qualifications
Skills, Experience, Education, & Training:

• BA or BS degree or equivalent and 10 or more years related experience in Supplier Management and Development, with significant medical or medical device experience
• Minimum 5 years of experience leading supplier development or supplier quality engineering teams, or leadership of equivalent areas.
• Proven ability to lead teams to solve difficult technical and process problems
• Proven ability to hire highly capable staff, and grow and mentor staff
• Proven track record of defining and pursuing excellence
• Deep knowledge of supplier manufacturing processes, to include but not limited to: metal fabrication (machining, turning, molding, stamping, casting), joining and finishing, plastic injection molding and extrusion and wire cabling, MIM, PCA manufacture, disposable medical instruments, robotics components, or sensors/actuators
• Proven track record of managing to full regulatory compliance in the Supplier areas, both at suppliers and within Supplier Development Function
• Excellent knowledge of GMPs and experience with a highly complex medical device
• Excellent knowledge of Lean Manufacturing techniques and best practices, with demonstrated ability to articulate vision to the supplier base, peer group, and direct reports
• Excellent communication skills (written and verbal); outstanding ability to guide and teach proper technical writing
• Ability to read and interpret detailed mechanical drawings and communicating technical information
• Significant computer experience using Windows, Word, Excel and Access and ERP Information Systems, preferably SAP and Agile application software
• Sense of purpose combined with a strong ability to execute

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 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.
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.