Component Engineer 3

Serve as the primary technical interface between plant manufacturing teams and suppliers for quality issues, line disruptions, yield loss, delivery concerns, and capacity constraints. Approve and manage supplier process changes including new equipment, process transfers, facility moves, tooling changes, and production line validations.

Our Client, an American Biotechnology company, is looking for a Component Engineer 3 for their Sunnyvale, CA location.
 
Responsibilities:

• Supplier Performance & Plant Support
• 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.
• Supplier Manufacturing Process Improvement:
• 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.
• Supplier Qualification, Validation & Change Management:
• 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.
• Risk Mitigation & Operational Excellence:
• 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.
• Cross-Functional Partnership & Communication:
• 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 client and the supply base.
• Provide technical recommendations and supplier performance updates with minimal supervision.
• Perform other related duties as assigned.

 
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 preferred
• Experience supporting New Product Introduction (NPI) and production scaling preferred
• Technical Skills & Systems:
• 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 preferred
• Experience with Minitab or statistical analysis software preferred
• CAD / 3D modeling experience is a plus
• Additional Skills:
• 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
• Preferred Qualifications:
• Knowledge of 21 CFR Part 820 and ISO 13485 preferred
• Six Sigma certification or Lean Manufacturing certification preferred
• Experience working directly with external suppliers and contract manufacturers preferred
• Experience supporting production issue escalation and supplier recovery activities preferred
• Core Technical Expertise
• Strong background in:
• PCBA (Printed Circuit Board Assembly)
• SMT (Surface Mount Technology), through-hole processes
• Electronic components (ICs, connectors, sensors, cables, harnesses)
• Understanding of:
• Soldering processes (reflow, wave)
• IPC standards (IPC-A-610, J-STD-001)
• ESD controls and reliability concerns
• Supplier Process & Quality Focus
• Experience with:
• Electronics failure analysis (signal integrity, shorts/opens, component failures)
• Environmental and reliability testing (thermal cycling, vibration)
• Ability to investigate:
• Field returns, intermittent failures, firmware/hardware integration issues

 
Why Should You Apply?

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities