Component Compliance Engineer IV

5 days ago

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

Job Description 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 companys 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 KSIs 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 devices 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 LI - LS1

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