Amick Brown is seeking an experienced Component Engineer for our direct client.
Location: Sunnyvale, CA
Duration: 12 Months
Estimated pay range: $68– 85 per client contract and candidate skills, experience and work location.
Job Description
Role Description:
Location: Sunnyvale, CA
Duration: 12 Months
Estimated pay range: $68– 85 per client contract and candidate skills, experience and work location.
Job Description
Role Description:
- Joining our clients means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
- 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.
- Part Qualification
- Lead Part Qualification activities in support of NPI programs
- Lead Core Product Teams in defining appropriate Part Qualification requirements
- This includes defining testing and inspection requirements prior to system integration in order to maximize ISI factory efficiency
- Support transfer of parts and suppliers from NPI to Sustaining production
- 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 Line Support during NPI manufacturing
- Quickly address potential line down incidents
- Take ownership of dispositioning non-conforming material and address systemic or
- significant non-conformances with formal corrective actions
- 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
- In order to adequately perform the responsibilities of this position the individual must possess:
- BS degree in Engineering field
- 7+ 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 at least two of the following categories:
- Machining, including 4 & 5-axis holdings, FMS and bar-fed lathes
- Metal Fabrication, Welding and/or other bonding processes
- Stamping & Fine blanking
- Die casting or Thixomolding
- Mechanical Motion Products (Bearings, Gears and Screws)
- Mechanical Motion Control Products (Motors, Brakes)
- Motion Control Sensors (Encoders, Inertial Sensors, Resolvers
- 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
- We are an AA/EEO/Veterans/Disabled employer
- Component Engineer: Sources, selects, and qualifies components used in the company?s technology.
- Investigates alternate component technologies or supplies, reducing cost and improving quality and reliability.
- Acts as technical interface between component/production suppliers and development engineers, determining new and alternate sources.
- Investigates alternate component technologies or supplies for reduced cost or improved quality and reliability, and implements changes.
- Develops guidelines/procedures on vendor selection. Evaluates supplier change notification and qualifies changes, as needed.
- May maintain component data management system including qualification records/results/documentation.
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Seniority level
Mid-Senior level -
Employment type
Contract -
Job function
Engineering and Information Technology -
Industries
Information Technology & Services
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