10 years related experience in Manufacturing, Supplier Process Engineering, or Design
Excellent written and verbal communication skills
Experience creating and aggregating DFM feedback
Demonstrable knowledge in evaluating supplier technical, quality, and business capabilities
Familiarity with key manufacturing processes relevant to cost and capacity
Experience or knowledge of ISO 13485 and 21 CFR part 820
Responsibilities
Support Value Engineering and Quality Improvement Part Qualification efforts
Lead Core Product Teams in defining Part Qualification requirements
Define testing and inspection requirements to maximize factory efficiency
Complete Production Part Qualification Process deliverables and risk analysis
Drive improvements to ISI requirements through specifications and drawings management
Manage supplier change management projects post Design V&V
Evaluate high capability suppliers necessary for New Products
Benefits
Support for professional development and certification
Opportunity to work with diverse manufacturing processes
Exposure to advanced engineering and quality systems
Collaborative work environment with cross-functional teams
Potential for international travel to suppliers
Full Job Description
Job Description: The mission of Supplier Engineering is to ensure high quality and stable delivery of purchased production components from suppliers operating under robust quality systems. Each supplier engineer is responsible for ensuring suppliers meet ISI requirements for product quality, cost, and service. Roles and 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
Skill/Job 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
Ability to travel to suppliers on an as needed basis - domestic and international
