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Component Engineer 3

Iconma

Sunnyvale, CA

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JOB DETAILS
SKILLS
3D Modeling, Auditing, Best Practices, Business Processes, CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), Capacity Analysis, Change Requests/Orders, Code of Federal Regulations, Communication Skills, Computer Skills, Continuous Improvement, Corrective Action, Cost Control, ERP (Enterprise Resource Planning), Health Plan, ISO (International Organization for Standardization), Information Technology & Information Systems, Lean Six Sigma, Manufacturing/Industrial Processes, Medical Equipment, Metrics, Microsoft Access Database, Microsoft Excel, Microsoft Windows Operating System, Microsoft Word, Negotiation Skills, Performance Analysis, Performance Management, Presentation/Verbal Skills, Problem Solving Skills, Process Capability, Process Improvement, Product/Service Launch, Project/Program Management, Quality Management, SAP, Scorecarding, Site Evaluation, Strategic Planning, Technical Drawing, Vendor/Supplier Evaluation, Vendor/Supplier Management, Vendor/Supplier Planning, Vendor/Supplier Selection, Writing Skills
LOCATION
Sunnyvale, CA
POSTED
8 days ago
Our Client, a Medical Technology company, is looking for a Component Engineer 3 for their Sunnyvale, CA location.
 
Responsibilities:
  • Responsible for ensuring suppliers meet ISI requirements for cost, quality, delivery and service.
  • Drive suppliers to continuously improve business and manufacturing processes.
  • Evaluate and select suppliers.
  • Guide Engineering in choosing suppliers for new products and provide DFM input to new designs.
  • Monitor supplier performance.
  • Select and evaluate suppliers by leading efforts to find new suppliers in an existing or new commodity.
  • Conduct on-site supplier assessments as well as QMS audits and address the non-conformities.
  • Work with suppliers and ISI engineering for the new product introduction to
  • Complete part production qualification process ( PPQP), which includes but not limited to delivering on the following deliverables: spFMEA, Special Process Validations, Process capability, MSA, capacity analysis ,and FAIR .
  • Develop supplier ramp readiness based on forecast, supplier capacity, quality performance, and process capability.
  • Perform DFM by engaging suppliers early in development cycle to feedback manufacturability improvements in the designs prior to production
  • Lead and resolve the supply continuity/ quality issues at suppliers through in depth root cause and corrective actions utilizing SCARs, SCRs (Supplier Change requests) processes.
  • Monitor supplier performance and initiate improvement activities.
  • Drive suppliers to continually improve their business and manufacturing process performance to meet Intuitive Surgical’s requirements for supplier excellence including ship to stock programs using a collection of best practices in project management, Six Sigma, Lean, SPC and negotiation by leading these efforts without managerial guidance at several suppliers simultaneously.
  • Develop and use metrics for supplier part cost, delivery, quality, capacity and capability by creating metrics to measure real improvement and judge required intervention or change at the supplier or in a commodity.
  • Driving change to ISI specifications as necessary by understanding and changing specifications and drawings including driving the ECO process to implementation.
  • Prepare and deliver supplier communications as required by independently working with suppliers on scorecard creation of QBRs, Supplier Summits, etc.
  • Identify and investigate opportunities for cost reduction and/or quality improvement by judging opportunities and creating strategies to seize those opportunities, completes research and provides data-driven plans to management.
 
Requirements:
  • In order to adequately perform the responsibilities of this position the individual must possess:
  • BS degree in Engineering or equivalent, Masters degree preferred
  • Excellent knowledge of 21 CFR part 820 and ISO 13485 (experience in auditing suppliers to these standards): Certified Lead auditor preferred, but not required
  • Practical knowledge of pfmeas and process validations
  • Ability to read and interpret detailed mechanical drawings and communicate technical information
  • Excellent problem solving and project management skills
  • Excellent written and verbal communication skills including presentations to executive level management
  • A proven history of implementing Lean/6 Sigma/SPC Programs at suppliers
  • Practical knowledge of part production qualification process
  • Significant computer experience using Windows, Word, Excel, Access and ERP Information Systems, preferably SAP
  • CAD experience with 3D modeling tools is a plus
  • Experience in a high-volume medical device company is a plus
 
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/