Component Compliance Engineer IV

3 weeks ago


Goleta, California, United States KARL STORZ Endoscopy - America Full time
Component Compliance Engineer IV

We are seeking an experienced Component Compliance Engineer IV to join our team at KARL STORZ Endoscopy - America. As a key member of our engineering team, you will be responsible for leading component selection, qualification, and management for medical devices.

Key Responsibilities:
  • Develop and maintain global guidelines for component selection and usage.
  • Collaborate with cross-functional teams to resolve component-related issues.
  • Analyze electronic component data sheets and characteristics for specific circuit applications.
  • Improve department processes related to component selection and qualification.
  • Provide technical support for design, manufacturing, and quality teams.
  • Create and maintain Engineering Specification sheets.
  • Support Electronics Engineers on component analysis, specifications, target costs, and cost reductions.
  • Originate and update component definitions and entries into the parts library for schematic and PWB design tools.
  • Participate in design reviews and contribute to design optimization.
  • Develop analytical and test methods to quantify component characteristics.
Requirements:
  • Bachelor's or Master's degree in Electrical Engineering, Component Engineering, or related field.
  • 8+ years of experience in electronics design and analysis, with 10+ years in component engineering.
  • Knowledge of FDA Quality System Regulation (21 CFR Part 820) and international quality standards (ISO 13485, ISO 9001).
  • Excellent communication, problem-solving, and analytical skills.
Preferred Qualifications:
  • Experience with image sensors, FPGAs, microprocessors, and memory.
  • Familiarity with video systems, CCD and CMOS imager technology, and Endoscopy in Medical Devices.
  • Altium schematic and PWB design tool experience.

We offer a dynamic work environment, opportunities for professional growth, and a competitive compensation package. If you are a motivated and experienced Component Compliance Engineer IV looking for a new challenge, please submit your application.



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