Supplier Engineer - ION

Intuitive•Sunnyvale, CA

10d

About The Position

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 a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care. 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.

Requirements

BS degree in Engineering or equivalent, experience in catheter development preferred
Minimum 5 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
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

Nice To Haves

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

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
Partner with global supply chain to optimize the supply base
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
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.
Manage the ASL and Global Commodity Matrix
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 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.