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Senior Component Specialist
2 months ago
Key Responsibilities:
- Lead component discussions with cross-functional teams globally, driving the establishment of global standards and processes.
- Collaborate with multi-functional teams to resolve complex vendor-related component issues.
- Select and qualify components used in the company's technology.
- Act as a technical interface between component/production suppliers and development engineers to improve quality and reliability.
- Assist in determining new and alternate sources to reduce costs.
Main Responsibilities:
- Provide leadership and technical support to the department in 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.
- Support component compliance along with QA and Material compliance teams for new additions 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.
- Evaluate supplier change notification and qualify changes, as needed.
Secondary Duties:
- 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.
- Perform other related duties as assigned by supervisor.
Requirements:
- 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.
Qualifications:
- 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.
- 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.
Work Environment:
- 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.