Component Compliance Engineer IV

5 days ago

Santa Ynez, California, United States Karl Storz Endoscopy-America Full time
Job Summary

As a key member of the Karl Storz Endoscopy-America team, the Component Compliance Engineer IV will play a critical role in ensuring the quality and reliability of our medical devices. This position will lead component discussions with cross-functional teams globally, establish global standards and processes, and select and qualify components used in our technology.

Key Responsibilities
  • Provide leadership and technical support to the department in 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.
  • Support and maintain component compliance along with QA and Material compliance teams for new additions 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.
  • Evaluate supplier change notification and qualifies changes, as needed.
  • 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.
Requirements
  • 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.
  • 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 and Mental Demands
  • 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.

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