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Component Compliance Engineer IV

2 months ago

Goleta CA United States KARL STORZ Endoscopy - America Full time

 

At KARL STORZ, we are driven by a mission to enhance global health through innovative technology designed to tackle the most complex surgical procedures and medical challenges.

 

To achieve this mission, we're seeking experienced Application and Electrical Engineers or Component Engineers with a strong technical background in and passion for identifying specialized components targeted for our unique design application to join our team, where you'll leverage your expertise to solve complex engineering challenges and drive medical technology innovation.

 

KEY RESPONSIBILITIES:

  • Lead component selection, qualification, and management for medical devices.

  • 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.

UNLOCK YOUR TECHNICAL EXPERTISE:

Join our team and:

  • Solve Complex Challenges: Tackle intricate engineering problems that require innovative solutions,

  • Advance Your Technical Skills: Stay up-to-date with the latest technologies and industry trends through ongoing training and professional development.

  • Collaborate with Experts: Work alongside experienced engineers and cross-functional teams to drive medical technology innovation.

  • Design and Develop Cutting-Edge Products: Contribute to the creation of life-changing medical devices and solutions.

  • Optimize System Performance: Apply your expertise to optimize component selection, design, and testing for maximum efficiency.

  • Recognition for Technical Excellence: Receive recognition and rewards for your technical achievements and contributions.

WHO WE ARE:

KARL STORZ is an independent, family-owned company headquartered in Germany’s renowned MedTech manufacturing region. For 80 years, we've pioneered the most groundbreaking innovations in endoscopic surgery, video imaging, and OR integration to benefit patients and healthcare providers alike. 

 

With more than 9,000 associates worldwide and 2,600 in the US, we pride ourselves on harnessing cutting-edge technology, precise workmanship, and unrivaled customer support to help healthcare facilities succeed. With onsite locations and field opportunities across the country, we attract a diverse and talented staff.  It's not just about the tools we create—it’s about the lives we change, together.

 

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