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Component Compliance Specialist
2 months ago
Job Title: Component Compliance Specialist
Job Summary: We are seeking a highly skilled Component Compliance Specialist to join our team at KARL STORZ Endoscopy - America. The successful candidate will play a key role in establishing global standards and processes for component selection and qualification.
Key Responsibilities- Component Selection and Qualification: Lead component discussions with cross-functional teams globally, and select and qualify components used in our technology.
- Technical Interface: Act as a technical interface between component/production suppliers and development engineers to improve quality and reliability.
- Process Development: Develop and maintain global guidelines such as preferred parts, derating, and tolerance analysis.
- Component Analysis: Support Electronics Engineers on component analysis, specifications, target costs, and cost reductions.
- Engineering Specification Sheets: Originate and update Engineering Specification sheets.
- Component Compliance: Support and maintain component compliance along with QA and Material compliance teams for new additions like China RoHS and REACH.
- Component Library: Provide component definition and entry into the parts library for schematic and PWB design tools.
- EOL Projections: Improve End-of Life (EOL) projections during product development for long production life.
- Regular EOL Meetings: Represent Engineering in regular EOL meetings with Purchasing, Manufacturing, and Quality departments.
- Component Issues: Support Purchasing, Manufacturing, and contract manufacturers to resolve component issues with existing product lines.
- Component Analysis and Modeling: Develop analytical and test methods to objectively quantify component characteristics.
- Documentation: Document results in technical reports and design review presentations.
- Quality: Perform all activities associated with this position with the highest level of quality standards recognizing that our products are used in the medical industry.
- Durability: Address the long-term durability of the design in all activities associated with this position.
- Efficacy: Consider the device's final application in all activities associated with this position.
- Other Duties: Perform other related duties as assigned by supervisor.
- Quality System Regulation: 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.
- Component Data Sheets: Evaluate electronic component data sheets and characteristics and their applicability to specific circuit applications.
- Process Improvement: Improve and create department processes related to component selection and qualification.
- Attention to Detail: Must be detail-oriented with high accuracy.
- Test Equipment: Must be able to understand/operate advanced test equipment.
- Communication Skills: Must have excellent oral and written communication skills.
- Education: 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: Design familiarity with image sensors, FPGAs, microprocessors, and memory, preferred.
- Video Systems: Experience with and knowledge of video systems and CCD and CMOS imager technology, preferred.
- Medical Device Industry: Familiarity with Endoscopy in a Medical Device company a plus.
- Visual Acuity: Visual acuity sufficient for testing.
- Sitting and Lifting: Ability to sit for extended periods (during meetings and computer work) and lift video and test equipment (approx. 15 lbs).
- Electrical Connections: Ability to connect electrical devices.
- Injury and Illness Prevention Program: Injury and Illness Prevention Program; annually - OSHA requirement.
- Job Specific Training: Job Specific - In house requirement.