Supplier Engineer

Supplier Engineer

Requirements

• Minimum BS degree in Engineering or equivalent.
• 3-6 years related experience in Manufacturing Engineering, Supplier Engineering, or related field.
• Experience utilizing project management skills
• Experience in analytical and trouble-shooting skills, and inspection and test techniques.
• Ability to read and interpret detailed specification drawings and communicate technical information.
• Experience in evaluating and supporting supplier-related issues.
• Knowledge of Supplier Process FMEA and Process Validation.
• Experience with manufacturing processes including understanding of key input variables for quality, cost, and capacity.

Responsibilities

• Partner with ISFMT SEs and ISI SEs at assigned suppliers using various tools and best practices including project management, Six Sigma, Lean and SPC.
• Include Change Control Management using Supplier Change Request (SCR) process, Engineering Change Order (ECO), and/or Process Change Notice (PCN).
• Perform and maintain product/process risk analyses and ensure mitigations are implemented and effective (Supplier Process FMEA).
• Establish and sustain capable processes at supplier sites.
• Work jointly with ISFMT SE to implement supplier manufacturing process selections.
• Help the ISFMT and Intuitive teams in overcoming difficult process issues encountered in the manufacture of components and assemblies.
• Investigate and resolve ISFMT Production line down events that are supplier caused.
• ISI-owned component/assembly drawing or MPI discrepancy corrections.
• Drive Inspection Correlation analyses and corrections between ISFMT, ISI and suppliers.
• Disposition non-conforming material (Containment).
• In-depth Root Cause Analysis.
• Implement Corrective Actions/Preventive Actions.
• Capture all ISI and ISFMT record evidence of CAPA actions.
• Partner with ISFMT SE to provide effective and timely supplier health information (Supplier Monitoring) to ISI and ISFMT management and the supplier through Scorecards, Strategic Business Reviews, and Quality Feeder meetings.
• Engage with ISFMT SE to help Production Part Qualification Process (PPQP) deliverables.
• Participate in the ISFMT Supplier Selection Evaluation team and ensure all quality aspects of the intended supplier are considered; actions may include: Control Plan audit, QMS audit, First Article Inspection, Special Process Validation, Process Capability Research.
• Partner between ISFMT Purchasing/Materials organization and ISI Purchasing/Materials organization with respect to supplier selection, evaluations, onboarding, and monitoring.
• Lead Auditor or Backup Auditor functions in helping of ISFMT 13485 audit requirements.
• Drive ISI and supplier SCAR processes to resolve non-conformities.

Preferred Qualifications

• Computer experience using Windows, MS Office Suite, SAP (or other ERP system), and Agile (or other PLM system).
• Ability to travel to suppliers on an as needed basis – domestic and international (max travel per quarter is 30%).
• Flexible working hours to help China Operations organization.
• Verbal fluency in Mandarin Chinese would be a plus.
• Knowledge of Six Sigma and Lean Manufacturing techniques.
• Knowledge of 21 CFR part 820 and ISO 13485 (experience in auditing suppliers to these standards).
• CAD experience with 3D modeling tools or schematic capture tools.
• Experience in a high-volume medical device company.