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Component Engineer 4

Iconma

Sunnyvale, CA

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JOB DETAILS
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
8 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?
  • Health Benefits
  • Referral Program
  • Excellent growth and advancement opportunities
 
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

I

Iconma

ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.

  • Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
  • Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
  • Founded in 2000
  • 2000+ Employees

The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Management Consulting Services
EMPLOYEE BENEFITS
401K, Employee Referral Program, Life Insurance
FOUNDED
2000
WEBSITE
https://www.iconma.com/

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