Component Compliance Engineer III

2 weeks ago

Isla Vista, 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

#LI - LS1

Get in Contact

  • Systems Engineer IV

    2 weeks ago

    Isla Vista, United States KARL STORZ Endoscopy - America Full time

    JOB SUMMARY:Responsible for product design at system level. He/she works closely together with product management, project management, development, and production in order to design a product that fulfills customer, manufacturing, service, market and regulatory requirements. Responsible for system requirements and system architecture, reviews sub-system...

  • Test Engineer II

    3 days ago

    Isla Vista, United States KARL STORZ Endoscopy - America Full time

    JOB SUMMARY: Brief description of what this person does, in simple direct termsUnder minimal supervision, provides design verification support for Karl Storz products to verify that they meet quality standards, including the design and execution of approved verification procedures, the execution of studies and troubleshooting in support of design...

  • Image Processing Engineer V

    2 weeks ago

    Isla Vista, United States KARL STORZ Endoscopy - America Full time

    JOB SUMMARY: Brief description of what this person does, in simple direct terms. Produce advanced designs for camera image processing. Design, analyze, demonstrate, and implement image and video processing methods for camera product development. Perform research and development to produce new image processing solutions for existing and future...

  • Onsite Job: Manufacturing Engineer Level 2

    22 hours ago

    Isla Vista, United States Indotronix International Corporation Full time

    Onsite Job: Manufacturing Engineer Level 2 & 3 Location: Goleta, CA 93117 Duration: 12 Months Contract (After 9 months potentially conversion based on performance) Work Schedule: 9x80 Security Clearance: No Bachelors Degree in Engineering Level 2 - Min 2-5+ years exp Level 3 - Min 5-9+ years exp Job Description: Experience with...

  • Onsite Job: Manufacturing Engineer Level 2

    1 hour ago

    Isla Vista, United States Indotronix International Corporation Full time

    Onsite Job: Manufacturing Engineer Level 2 & 3 Location: Goleta, CA 93117 Duration: 12 Months Contract (After 9 months potentially conversion based on performance) Work Schedule: 9x80 Security Clearance: No Bachelors Degree in Engineering Level 2 - Min 2-5+ years exp Level 3 - Min 5-9+ years exp Job Description: Experience with...

  • Design Quality Engineer III

    3 days ago

    Vista, United States Enovis Full time

    Job Description:At Enovis™ we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence - with the goal of transforming medical technology as we know it.Because that's how we change the lives of patients for the better. And that's how we create better together.As a key member of the...

  • Design Quality Engineer III

    5 days ago

    Vista, United States DJO Global Full time

    Job Description: At Enovis we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence - with the goal of transforming medical technology as we know it. Because that's how we change the lives of patients for the better. And that's how we create better together. As a key member of the...

  • Process Engineer

    4 days ago

    Vista, United States Enovis Full time

    Job Description:At Enovis™ we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence - with the goal of transforming medical technology as we know it.Because that's how we change the lives of patients for the better. And that's how we create better together.As a key member of the...

  • Process Engineer

    5 days ago

    Vista, United States DJO Global Full time

    Job Description: At Enovis we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence - with the goal of transforming medical technology as we know it. Because that's how we change the lives of patients for the better. And that's how we create better together. As a key member of the...

  • Process Engineer

    2 days ago

    Vista, United States Enovis Full time

    Job Description: At Enovis™ we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence - with the goal of transforming medical technology as we know it. Because that's how we change the lives of patients for the better. And that's how we create better together. As a key member of...

  • Electrical Engineer

    1 month ago

    Vista, United States Nighthawk Flight Systems, Inc. Full time

    Nighthawk Flight Systems Inc. is a leading advanced avionics company dedicated torevolutionizing the aviation industry with cutting-edge solutions. Specializing in advancedcompact integrated avionics solutions for rotary and fixed-wing aircraft in the general aviation,business, air transport, and military markets. We pride ourselves on our commitment to...

  • Electrical Engineer

    3 days ago

    Vista, United States Nighthawk Flight Systems Inc. Full time

    Nighthawk Flight Systems Inc. is a leading advanced avionics company dedicated torevolutionizing the aviation industry with cutting-edge solutions. Specializing in advancedcompact integrated avionics solutions for rotary and fixed-wing aircraft in the general aviation,business, air transport, and military markets. We pride ourselves on our commitment to...

  • Identity and Access Management IdAM Engineer

    3 weeks ago

    Sierra Vista, United States Link Solutions Full time

    Job Description Link Solutions is seeking an Identity and Access Management (IdAM) Engineer to join our team in Sierra Vista, Arizona. Must be a US Citizen Non-remote (relocation incentive available) The Identity and Access Management (IdAM) Engineer will provide mission support to the U.S. Army Network Enterprise Technology Command (NETCOM) located on Fort...

  • Mechanical Engineer

    1 month ago

    Vista, United States Nighthawk Flight Systems, Inc. Full time

    Nighthawk Flight Systems Inc. is a leading advanced avionics company dedicated torevolutionizing the aviation industry with cutting-edge solutions. Specializing in advancedcompact integrated avionics solutions for rotary and fixed-wing aircraft in the general aviation,business, air transport, and military markets. We pride ourselves on our commitment to...

  • Mechanical Engineer

    1 week ago

    Vista, United States Nighthawk Flight Systems Inc. Full time

    Nighthawk Flight Systems Inc. is a leading advanced avionics company dedicated torevolutionizing the aviation industry with cutting-edge solutions. Specializing in advancedcompact integrated avionics solutions for rotary and fixed-wing aircraft in the general aviation,business, air transport, and military markets. We pride ourselves on our commitment to...

  • Engineering Technician

    4 days ago

    Chula Vista, United States Delphinus Engineering Full time

    EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law. DescriptionGENERAL SUMMARY: Coordinates interdisciplinary engineering...

  • Electrician III

    5 days ago

    Chula Vista, United States Delphinus Engineering Full time

    EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law. DescriptionSALARY: $30.00 - $36.00 per hour BENEFITS: All eligible full time...

  • Substation Protection and Control Engineer II/III

    4 days ago

    Tahoe Vista, United States Liberty Utilities Full time

    Substation Protection and Control Engineer II/III Tahoe Vista, CA, US, 96148 Our purpose is sustaining energy and water for life, and it is demonstrated in everything we do as a business, and as an employee team. At Liberty, we hire passionate people who care about doing the right thing for our customers. We are entrepreneurial, creative, and...

  • Sheet Metal Mechanic III

    5 days ago

    Chula Vista, United States Delphinus Engineering Full time

    EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law. Description SALARY: $30.00 - $36.00 per hourBENEFITS: All eligible full time...

  • Identity and Access Management

    2 days ago

    Sierra Vista, United States Link Solutions Full time

    Job Description Link Solutions is seeking an Identity and Access Management (IdAM) Engineer to join our team in Sierra Vista, Arizona.  Must be a US Citizen  Non-remote (relocation incentive available) The Identity and Access Management (IdAM) Engineer will provide mission support to the U.S. Army Network Enterprise Technology Command (NETCOM)...