Component Engineer 4

Component Engineer 4#26-13446 $91.11-$93.33 per hour Sunnyvale, CA 40% Remote Job Description 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 ICONMA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to any status protected by applicable law.