Component Engineer 4

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 ISIs 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 consideration for employment without regard to any status protected by applicable law.