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Skills
Biotech and Pharmaceuticalunmatched
Corrective Actionunmatched
Cross-Functionalunmatched
Electricityunmatched
Electromechanical Assemblyunmatched
Electromechanicsunmatched
Health Planunmatched
Inventory Transactionsunmatched
Machine Toolunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Manufacturing Engineeringunmatched
Manufacturing/Industrial Processesunmatched
Problem Solving Skillsunmatched
Process Capabilityunmatched
Process Developmentunmatched
Process Improvementunmatched
Process Validationunmatched
Product Supportunmatched
Product/Service Launchunmatched
Prototypingunmatched
Purchasing/Procurementunmatched
Quality Engineeringunmatched
Regulatory Complianceunmatched
Riskunmatched
Risk Analysisunmatched
Root Cause Analysisunmatched
Supply Chain Operationsunmatched
Technical Supportunmatched
Technical/Engineering Designunmatched
Traceabilityunmatched
Vendor/Supplier Evaluationunmatched
Vendor/Supplier Selectionunmatched
Description
Our Client, an American Biotechnology company, is looking for a Coponent Engineer 4 for their Sunnyvale, CA location.
Responsibilities:
Support New Product Introduction (NPI) programs by working with suppliers and cross-functional teams to ensure material readiness, quality, and manufacturability.
Support early-stage material procurement activities, including supplier engagement, technical readiness assessments, and execution of prototype and development builds.
Communicate technical requirements, specifications, drawings, quality expectations, and inspection requirements to suppliers.
Review and disposition non-conforming materials through Variance Requests (VRs), utilizing technical judgment and risk-based decision making.
Review First Article Inspection Reports (FAIRs), inspection methods, measurement systems, fixtures, and tooling to ensure compliance with requirements.
Understand manufacturing processes for mechanical, electrical, or electromechanical components and identify process risks, failure modes, and opportunities for improvement.
Investigate supplier quality and manufacturing issues, perform root cause analysis, and drive Supplier Corrective Action Requests (SCARs) to effective closure.
Understand and apply material traceability requirements, including the ability to trace supplier lots through incoming inspection, inventory transactions, production kitting, and finished product records.
Support supplier qualification, process validation, and production readiness activities.
Partner with suppliers to improve process capability, quality, manufacturability, and inspection effectiveness.
Collaborate with Design Engineering, Manufacturing Engineering, Quality Engineering, Operations, and Supply Chain to resolve technical issues and support product launches.
Develop commodity expertise in mechanical, electrical, or electromechanical components, assemblies, and manufacturing processes.
Communicate technical issues, risks, and recommendations effectively to suppliers and internal stakeholders.