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 collaborate on supplier selection with cross functional partners. Supports sustaining production monitors and engages with suppliers to improve supplier performance.
Roles & Responsibilities:
Part qualification including pFMEAs FAIRS Cpk Control Plans
Key point of contact for Ion BU to communicate Regulated Material requirements to suppliers track and receive regulated materials declarations from suppliers and verify the compliance status has been approved prior to qualifying the part for production.
Partner with Regulatory and Environmental Management teams to streamline processes with use of Lean Six Sigma and Process mapping and develop training for the supplier engineering team.
Obtain and monitor supplier hardware certifications and renewal dates to ensure part compliance across regions worldwide.
Support global expansion teams with managing and completing product labeling qualifications.
Support Environmental Management initiatives by obtaining part material information from suppliers and executing projects when needed to modify or change part to meet the new environmental regulations.
Supplier Corrective Action Request initiation execution and closure
Partner with global supply chain to optimize the supply base
Drive suppliers to continually improve their business and manufacturing process performance to meet Intuitive Surgicals requirements for supplier excellence including ship to stock programs using a collection of best practices in project management Six Sigma Lean SPC and negotiation
Utilize data-driven decisions to evaluate supplier part cost delivery quality capacity and capability. Apply 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.
Provide effective and timely supply base health information to management
Prepare and deliver supplier communications as required by working with suppliers on scorecard creation of QBRs Supplier Summits etc.
Deliver the following Quality deliverables: pFMEA Special Process Validations FAI and Cpk by leading 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 :
Qualifications
Skills Experience Education & Training:
BS degree in Engineering or equivalent experience
Minimum 3 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
Experience inimplementing Lean/6 Sigma/SPC Programs
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
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) is a plus
Excellent knowledge of 21 CFR part 820 and ISO 13485
Significant computer experience using Windows Word Excel Access and ERP Information Systems preferably SAP
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 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 governments 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 employeesstart 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.
Remote Work :
No
Employment Type :
Full-time
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As pioneer and leading company in the field of robotic-assi ... View more