Sign upLog in
Engineering Jobs

Component Engineer 3

ICONMA, LLC

Sunnyvale, CA

Apply
JOB DETAILS
SALARY
$60–$75 Per Hour
SKILLS
3D Modeling, Agile Programming Methodologies, Analysis Skills, Biomedical Engineering, CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), Change Management, Change Requests/Orders, Code of Federal Regulations, Communication Skills, Continuous Improvement, Contract Manufacturing, Corrective Action, Cross-Functional, Data Analysis, Document Management, ERP (Enterprise Resource Planning), Extrusion, Health Plan, ISO (International Organization for Standardization), Injection Molding, Leadership, Lean Manufacturing, Lean Six Sigma, Machine Tool, Machining, Manufacturing, Manufacturing Engineering, Manufacturing Operations, Manufacturing/Industrial Processes, Mechanical Engineering, Medical Equipment, Microsoft Excel, Microsoft Word, Minitab, Multitasking, Operational Audit, Operational Strategy, Operational Support, Operations Planning, Operations Processes, Organizational Skills, Performance Analysis, Performance Metrics, Problem Solving Skills, Process Analysis, Process Capability, Process Control Engineering, Process Failure Mode and Effects Analysis (PFMEA), Process Improvement, Process Management, Process Manufacturing, Process Validation, Procurement Planning, Product Support, Product/Service Launch, Production Support, Productivity Management, Quality Engineering, Risk, Risk Management, Root Cause Analysis, SAP, Six Sigma Certification, Statistical Analysis System (SAS), Statistics, Statistics Software, Supply Chain, Supply Chain Management, Technical/Engineering Design, Vendor/Supplier Evaluation, Vendor/Supplier Management, Vendor/Supplier Planning, Vendor/Supplier Relations, Vendor/Supplier Selection
LOCATION
Sunnyvale, CA
POSTED
3 days ago
Our client, a Medical Technology company, is looking for a Component Engineer 3 for their Sunnyvale, CA location.
 
Responsibilities:
  • The Supplier Engineer is responsible for ensuring suppliers reliably support plant production by meeting client requirements for quality, delivery, capacity, cost, and service. This role is highly execution-focused and 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 across the supply base.
  • This position owns supplier performance for assigned commodities and components supporting plant production, with direct accountability for issue resolution, process capability, risk mitigation, and long-term supplier health.
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
  • 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
  • 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
  • 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
 
Why Should You Apply?  
 

About the Company

I

ICONMA, LLC

Similar Job Searches

Aerospace Engineer JobsApplication Engineer JobsApplications Engineer JobsAssistant Engineer JobsAutomation Engineer JobsBridge Engineer JobsBuilding Engineer JobsBuilding Technician JobsCad Engineer JobsCalibration Engineer Jobs