Component Engineer 3

Location: Sunnyvale, CA • Duration: 12+ months

About the Role

The Supplier Engineer ensures suppliers reliably support plant production by meeting requirements for quality, delivery, capacity, cost, and service. This execution-focused role serves as the primary technical interface between the plant and suppliers to resolve line-impacting issues, improve supplier manufacturing processes, and maintain stable production operations across multiple product families. The Supplier Engineer partners closely with Manufacturing, Quality, Planning, Operations, Design Engineering, Commodity/Supply Chain Engineering, and Procurement to drive supplier performance, qualify manufacturing processes, support New Product Introduction (NPI), and execute continuous improvement initiatives.

Responsibilities

• Serve as the primary technical interface between plant manufacturing teams and suppliers for quality issues, line disruptions, yield loss, delivery concerns, and capacity constraints.
• Lead supplier issue resolution from containment through root cause investigation and corrective/preventive action implementation.
• Support manufacturing operations by investigating and resolving supplier-related deviations, variances, nonconformances, and first article issues.
• Monitor supplier performance across quality, delivery, responsiveness, and manufacturing stability, driving improvement where gaps exist.
• Support uninterrupted production by proactively managing supplier risks and escalating critical issues appropriately.
• Work directly with suppliers to improve manufacturing processes, process capability, inspection methods, and process controls.
• Drive sustainable corrective actions using structured problem-solving methodologies and data-driven analysis.
• Lead investigations into recurring defects, quality escapes, process variation, and manufacturing inefficiencies impacting production.
• Partner with suppliers to improve yield, reduce variability, and strengthen manufacturing robustness.
• Build and execute supplier development plans using Lean Manufacturing, Six Sigma, SPC, and continuous improvement principles.
• Own and execute supplier qualification and validation activities, including:
  • Supplier pFMEA
  • IQ/OQ/PQ and process validations
  • First Article Inspections and inspection reports
  • Gage R&R and process capability analysis (Cp/Cpk)
• Support execution and closure of Variance Requests (VRs), Supplier Change Requests (SCRs), and supplier-driven manufacturing changes.
• Approve and manage supplier process changes including new equipment, process transfers, facility moves, tooling changes, and production line validations.
• Support implementation of ECO changes impacting suppliers, ensuring validation and risk mitigation prior to production release.
• Assess supplier readiness and manufacturing capability to support sustaining production and NPI ramp activities.
• Identify and proactively manage supplier-related risks including quality, capacity, continuity, and manufacturing constraints.
• Convert recurring supplier issues into structured improvement initiatives to eliminate root causes.
• Drive continuous improvement projects focused on quality, operational efficiency, manufacturing consistency, and supply continuity.
• Generate and track supplier performance metrics and provide data-driven recommendations to improve supplier health and performance.
• Support supplier audits, process reviews, and operational assessments as required.
• Partner closely with Manufacturing, Quality, Supply Chain, Planning, Procurement, and Engineering teams to support plant objectives.
• Communicate supplier risks, issue status, recovery plans, and project updates clearly to cross-functional teams and leadership.
• Support New Product Introduction (NPI) activities by evaluating supplier readiness, process capability, validation strategy, and production ramp risk.
• Maintain strong supplier relationships to effectively partner between Intuitive Surgical and the supply base.

Requirements

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or equivalent technical discipline.
• Minimum 2–5 years of experience in Supplier Engineering, Manufacturing Engineering, Quality Engineering, Supplier Quality, or related field.
• Experience supporting high-volume manufacturing environments, preferably in medical devices or regulated industries.
• Hands-on experience with manufacturing processes such as machining, MIM, injection molding, stamping, extrusion, or assembly processes.
• Experience supporting New Product Introduction (NPI) and production scaling.
• Strong technical problem-solving and root cause investigation skills.
• Working knowledge of pFMEA, process validation, statistical analysis, SPC, inspection methodologies, and corrective action systems.
• Familiarity with Lean Manufacturing and Six Sigma methodologies.
• Proficiency in Microsoft Excel, Word, and Project.
• Experience with ERP and document management systems such as SAP and Agile.
• Experience with Minitab or statistical analysis software.
• CAD / 3D modeling experience is a plus.
• Strong analytical, organizational, and communication skills.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.
• Demonstrated ability to work cross-functionally and influence without direct authority.
• Ability to travel domestically and internationally as needed (approximately 25%).

Preferred Qualifications

• Knowledge of 21 CFR Part 820 and ISO 13485.
• Six Sigma certification or Lean Manufacturing certification.
• Experience working directly with external suppliers and contract manufacturers.
• Experience supporting production issue escalation and supplier recovery activities.

Skills

• PCBA (Printed Circuit Board Assembly) and SMT (Surface Mount Technology), through-hole processes.
• Electronic components (ICs, connectors, sensors, cables, harnesses).
• Soldering processes (reflow, wave).
• IPC standards (IPC-A-610, J-STD-001).
• ESD controls and reliability concerns.
• Electronics failure analysis (signal integrity, shorts/opens, component failures).
• Environmental and reliability testing (thermal cycling, vibration).
• Investigation of field returns, intermittent failures, firmware/hardware integration issues.
• Electronic test methods: ICT (In-Circuit Testing), Functional testing, AOI (Automated Optical Inspection), X-ray.
• Electronic process validation (PCBA line qualification).
• EMS (Electronics Manufacturing Services) supplier management.
• Knowledge of embedded systems integration (nice-to-have).

Benefits

• Competitive compensation.
• Comprehensive benefits, including medical, dental, vision, and retirement options.