Component Compliance Engineer III

2 weeks ago

Goleta CA, Santa Barbara County, CA, 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 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.

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 KSI's 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 device's 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


* We are unable to sponsor or take over sponsorship of an employment at this time

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