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Component Compliance Engineer IV

2 months ago

Santa Barbara, United States Karl Storz Endoscopy-America Full time

JOB SUMMARY:

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 companys 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.

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

  • Components

  • 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.

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

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

  • Originate and update Engineering Specification sheets.

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

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

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

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

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

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

  • Evaluates supplier change notification and qualifies changes, as needed.

  • Project Development Teams

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

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

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

  • Reduce costly over-specification of components

  • Contribute to design reviews.

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

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

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

  • 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.

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

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

  • Originate and update Engineering Specification sheets.

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

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

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

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

  • Analysis and Modeling

  • Develop analytical and test methods to objectively quantify component characteristics.

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

  • Document results in technical reports and design review presentations.

  • Regular attendance is an essential job function.


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

  • 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.

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

  • Efficacy all activities associated with this position must consider the devices final application.

  • Performs other related duties as assigned by supervisor.


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

  • 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.

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

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

  • Must be detail-oriented with high accuracy.

  • Must be able to understand/operate advanced test equipment.

  • Must have excellent oral and written communication skills.


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

  • 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

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

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

  • Familiarity with Endoscopy in a Medical Device company a plus


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

  • Visual acuity sufficient for testing.

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

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

  • Ability to connect electrical devices.


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

  • Injury and Illness Prevention Program; annually - OSHA requirement

  • Job Specific - In house requirement


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