Component Engineer 4

ICONMA, LLC

Sunnyvale, CA

JOB DETAILS
SALARY
$91.11–$93.33 Per Hour
SKILLS
8D, Assembly Line, Auditing, Biotech and Pharmaceutical, Business Analysis, Business Solutions, Change Management, Change Requests/Orders, Code of Federal Regulations, Commodity Management, Communication Skills, Computer Skills, Corrective Action, Cost Control, Cross-Functional, Customer Training, Die Casting, ERP (Enterprise Resource Planning), Health Plan, ISO (International Organization for Standardization), Information Technology & Information Systems, Lathe, Machining, Manufacturing, Manufacturing Methods, Manufacturing Process Engineering, Manufacturing/Industrial Processes, Medical Equipment, Metal Manufacturing, Microsoft Access Database, Microsoft Excel, Microsoft Windows Operating System, Microsoft Word, Motion Control, Operations Processes, Plastic Injection Molding, Presentation/Verbal Skills, Process Analysis, Process Capability, Process Development, Process Failure Mode and Effects Analysis (PFMEA), Process Improvement, Process Manufacturing, Process Quality, Process Validation, Product Design, Product/Service Launch, Production Systems, Quality Assurance Methodology, Quality Management, Requirements Management, Risk Analysis, Root Cause Analysis, SAP, Schematics, Supplier Relationship Management (SRM), Supply Chain, System Integration (SI), Team Lead/Manager, Test Requirements, Tool and Die Manufacturing, Value Engineering, Vendor/Supplier Evaluation, Vendor/Supplier Management, Vendor/Supplier Relations, Vendor/Supplier Selection, Welding, Writing Skills
LOCATION
Sunnyvale, CA
POSTED
30+ days ago
Our Client, an American Biotechnology company, is looking for a Component Engineer 4 for their Sunnyvale, CA/Hybrid location.
 
Responsibilities:
  • Part Qualification
  • Support Value Engineering and Quality Improvement Part Qualification efforts
  • Lead Core Product Teams in defining appropriate Part Qualification requirements
  • This includes defining testing and inspection requirements prior to system integration to maximize ISI factory efficiency
  • Support transfer of parts between suppliers
  • Complete Production Part Qualification Process deliverables:
  • Supplier pFMEA, Special Process Validations, FAI, and Process Capability Analysis
  • Perform product/process risk analysis and ensure mitigations are implemented and effective prior to product introduction
  • Establish sustainable process capability at supplier and critical sub-tier suppliers
  • Support Manufacturing Line Escalations from manufacturing teams
  • Drive corrective actions through use of various Root Cause tools (8D, 5 Why, etc), determining true root cause, implementing effective and lasting corrective and preventive actions
  • Manufacturing Process Selection and Development
  • Lead manufacturing process selection
  • Identify the correct process for manufacturing the part, considering process quality, long term capacity and total lifecycle cost.
  • Identify where DFM is appropriate to achieve higher quality, lower costs or better supply chain capacity
  • Educate internal customers and suppliers regarding supplier quality, process and operational capabilities, best value manufacturing methods and tooling for key supplier processes
  • Manage change
  • Drive improvements to ISI requirements as necessary by proposing and managing changes to specifications and drawings through the ECO process
  • Manage the planning and implementation of supplier change management projects using the Supplier Change Request process (SCR) post Design V&V
  • Provide status of the readiness (quality, capacity, delivery) of the supply chain for major production process changes
  • Work cross-functionally to improve supplier engineering processes
  • Supplier Selection and Evaluation
  • Support Supplier Selection
  • Work with Product Design, Commodity Mangers and other stake holders to identify high capability suppliers necessary for New Products based on assessment of business need and supplier capability.
  • Evaluate new supplies through informal assessments and formal assessment by supporting lead auditors in QMS evaluations
  • Foster Supplier Relationships
  • Support audit team in addressing findings to develop suppliers’ quality and business systems in order to meet ISI’s requirements
  • Manage supplier relationships to effectively partner with ISI suppliers
 
Requirements:
  • In order to adequately perform the responsibilities of this position the individual must possess:
  • BS degree in Engineering field
  • 10+ years related experience in Manufacturing, Supplier Process Engineering, Design, or related field
  • Excellent written and verbal communication skills
  • Experience creating and aggregating DFM feedback
  • Demonstrable knowledge in evaluating and challenging supplier technical, quality, and business capabilities
  • Experience with a wide range of manufacturing processes including understanding of key input variables for quality, cost and capacity
  • Desired product experience in the following categories:
  • Machining, including 4 & 5-axis holdings, FMS and bar-fed lathes
  • Metal Fabrication, Welding and/or other bonding processes
  • Plastic Injection Molding or other plastic forming processes
  • Die casting or Thixomolding
  • Mechanical Motion Products (Bearings, Gears and Screws)
  • Mechanical Motion Control Products (Motors, Brakes)
  • Motion Control Sensors (Encoders, Inertial Sensors, Resolvers)
  • Medical Gas Line Processing
  • Proven ability to motivate suppliers and lead teams to solve difficult technical and process problems
  • Knowledge of pFMEA, process validation, inspection and test techniques
  • Familiarity with 21 CFR part 820 and ISO 13485
  • Experience in auditing suppliers to these standards is preferred
  • At a minimum, candidate should understand GDP and QMS methods
  • Significant computer experience using Windows, Word, Excel, Access and ERP Information Systems, preferably SAP
  • Ability to read and interpret detailed specifications and schematics and communicate technical information
  • Experience in a medical device company is a preferred
  • Experience with low-volume high-mix production environments is a preferred
 
Why Should You Apply?  
ICONMA is an Equal Opportunity Employer. All qualified applicants will receive considerationfor employment without regard to any status protected by applicable law.
 

About the Company

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ICONMA, LLC