Component Compliance Engineer IV Job at KARL STORZ Endoscopy - America, Goleta, CA

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  • KARL STORZ Endoscopy - America
  • Goleta, CA

Job Description

Job Description

JOB SUMMARY:

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Lead component discussions with EEs globally, and play a key role in establishing global standards and processes. Lead multi-functional teams to solve complex vendor-related component issues. Selects, and qualifies components used in the company’s technology. Act as technical interface between component/production suppliers and development engineers to improve quality and reliability and to assist in determining new and alternate sources to reduce cost.

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ESSENTIAL FUNCTIONS: List the essential duties and responsibilities of the position, in order of importance and/or amount of time spent.

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    Components

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    Provide leadership and technical support to the department in the form of component recommendations, research, and documentation to enhance quality, manufacturability, reliability, and regulatory requirements.

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    Create and maintain global guidelines such as preferred parts, derating, and tolerance analysis.

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    Support Electronics Engineers on component analysis, specifications, target costs, and cost reductions.

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    Originate and update Engineering Specification sheets.

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    Supports and maintains component compliance along with QA and Material compliance teams for new additiona like China RoHS and REACH.

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    Provide component definition and entry into the parts library for schematic and PWB design tools.

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    Improve End-of Life (EOL) projections during product development for long production life.

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    Represent Engineering in regular EOL meetings with Purchasing, Manufacturing, and Quality departments.

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    Support Purchasing, Manufacturing, and contract manufacturers to resolve component issues with existing product lines.

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    Support Manufacturing, Quality and Engineering for component issues with existing product lines for such as selecting and analyzing potential End-Of-Life (EOL) replacements.

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    Evaluates supplier change notification and qualifies changes, as needed.

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    Project Development Teams

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    Contribute component ideas, constraints, trade-offs, and concerns to the Electronics Engineers.

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    Coordinate with Electronics Engineers to analyze new electronic circuitry per component and system specifications and target costs.

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    Reduce component and assembly costs by minimizing diversity of similar parts – maximize commonality.

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    Reduce costly over-specification of components

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    Contribute to design reviews.

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    Coordinate with Regulatory group to ensure regulatory compliance and auditing support – RoHS, REACH

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    Provide data to Mechanical and Thermal Engineers to optimize packaging, manufacturability, and reliability.

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    Participate occasionally with the development team to build and test prototypes.

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    Provide support to complete the documentation and production release of the product, including development of a Technical Transfer (Theory of Operation) to Manufacturing and Quality personnel.

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    Altium schematic and PWB design tool librarian – process requests for new parts to be entered into the Altium shared Global Library.

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    Work independently with departments such as Engineering, Project Management, Purchasing, Manufacturing and Quality to ensure consistently producible quality camera systems

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    Originate and update Engineering Specification sheets.

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    Provide analytical support and simulations of electronic component performance to the product development teams

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    Provide training and occasional seminar/tutorials on component characteristics and selection to Engineers.

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    Will spend part of his/her time as a member of continuous improvement teams undertaking projects and seeking ways to improve the quality of KSI’s products and services .

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    Research and recommend new design techniques for KSI, including new electronic components, analytical models, and techniques.

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    Analysis and Modeling

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    Develop analytical and test methods to objectively quantify component characteristics.

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    Determine, where appropriate, empirical methods to validate analytical models. If necessary, update the model assumptions and/or empirical methods to correlate the results.

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    Document results in technical reports and design review presentations.

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    Regular attendance is an essential job function.

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ADDITIONAL RESPONSIBILITES:  List other important functions that are secondary duties but may be time consuming.

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    Quality – all activities associated with this position must be performed with the highest level of quality standards recognizing that the products are used in the medical industry.

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    Durability – all activities associated with this position must address the long-term durability of the design.

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    Efficacy – all activities associated with this position must consider the device’s final application.

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    Performs other related duties as assigned by supervisor.

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KNOWLEDGE, SKILLS, ABILITIES:  What does a person in this position need to be able to do?

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    Knowledge of the U.S. FDA Quality System Regulation, 21 CFR Part 820 (QSR), and knowledge of international quality system standards, ISO 13485, ISO 9001.

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    Evaluate electronic component data sheets and characteristics and their applicability to specific circuit applications.

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    Improve and create department processes related to component selection and qualification.

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    Must be detail-oriented with high accuracy.

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    Must be able to understand/operate advanced test equipment.

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    Must have excellent oral and written communication skills.

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EDUCATION AND EXPERIENCE: What is the usual educational background and work experience of an individual qualified to perform this job?

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    Bachelor of Science degree, or Masters of Science degree, with at least 8 years of experience in electronics design and analysis of analog and digital circuits. And minimum 10 years’ experience with component engineering

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    Design familiarity with image sensors, FPGAs, microprocessors, and memory, preferred

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    Experience with and knowledge of video systems and CCD and CMOS imager technology, preferred

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    Familiarity with Endoscopy in a Medical Device company a plus

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PHYSICAL & MENTAL REQUIREMENTS: What are the specific physical and mental demands of this position?

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    Visual acuity sufficient for testing.

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    Ability to sit for extended periods (during meetings and computer work).

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    Ability to lift video and test equipment (approx. 15 lbs).

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    Ability to connect electrical devices.

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TRAINING REQUIREMENTS: Safety, regulatory compliance, legal & job specific.

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    Injury and Illness Prevention Program; annually - OSHA requirement

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    Job Specific - In house requirement

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#LI - LS1

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Job Tags

Contract work, Part time, Work experience placement,

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