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Senior Component Compliance Engineer

2 months ago

Goleta, California, United States KARL STORZ Endoscopy - America Full time

JOB SUMMARY:
Oversee global component discussions with Electrical Engineers and play a pivotal role in defining international standards and methodologies. Lead cross-functional teams to address intricate vendor-related component challenges. Responsible for the selection and qualification of components utilized in the company's technology.

Serve as the technical liaison between component suppliers and development engineers to enhance quality and reliability while identifying new and alternative sources to optimize costs.


ESSENTIAL FUNCTIONS:
Outline the primary duties and responsibilities of the role, prioritized by significance and/or time allocation.
Components


Provide leadership and technical guidance within the department through component recommendations, research, and documentation aimed at improving quality, manufacturability, reliability, and adherence to regulatory standards.

Establish and maintain global guidelines such as preferred components, derating practices, and tolerance assessments.

Assist Electronics Engineers with component evaluations, specifications, target pricing, and cost-saving initiatives.

Initiate and revise Engineering Specification documents.


Ensure component compliance in collaboration with Quality Assurance and Material Compliance teams for new regulations such as China RoHS and REACH.

Define components and manage entries into the parts library for schematic and PWB design tools.

Enhance End-of-Life (EOL) forecasts during product development to ensure prolonged production viability.

Represent Engineering in regular EOL discussions with Purchasing, Manufacturing, and Quality departments.

Support Purchasing, Manufacturing, and contract manufacturers in resolving component-related issues for existing product lines.


Assist Manufacturing, Quality, and Engineering teams with component challenges related to existing products, including the selection and analysis of potential EOL replacements.

Evaluate supplier change notifications and qualify changes as necessary.

Project Development Teams

Contribute component insights, constraints, trade-offs, and concerns to Electronics Engineers.

Collaborate with Electronics Engineers to assess new electronic circuitry against component and system specifications and target costs.

Minimize component and assembly costs by reducing the variety of similar parts and maximizing commonality.

Avoid excessive over-specification of components.

Participate in design reviews.

Coordinate with the Regulatory team to ensure compliance and support for audits - RoHS, REACH.

Provide data to Mechanical and Thermal Engineers to enhance packaging, manufacturability, and reliability.

Occasionally engage with the development team to construct and evaluate prototypes.


Assist in completing documentation and production release of products, including the development of a Technical Transfer (Theory of Operation) for Manufacturing and Quality personnel.


Manage Altium schematic and PWB design tool library - process requests for new parts to be added to 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.

Initiate and update Engineering Specification documents.

Provide analytical support and simulations of electronic component performance to product development teams.

Deliver training and occasional seminars/tutorials on component characteristics and selection to Engineers.


Participate as a member of continuous improvement teams, undertaking projects to enhance the quality of KSI's products and services.

Research and propose new design methodologies for KSI, including innovative electronic components, analytical models, and techniques.

Analysis and Modeling

Develop analytical and testing methods to objectively assess component characteristics.

Identify, where applicable, empirical methods to validate analytical models. Update model assumptions and/or empirical methods as necessary to correlate results.

Document findings in technical reports and design review presentations.

Regular attendance is a fundamental job requirement.

ADDITIONAL RESPONSIBILITIES:
Detail other significant functions that are secondary duties but may require considerable time.

Quality - all tasks associated with this position must be executed with the utmost quality standards, recognizing that the products are utilized in the medical sector.

Durability - all tasks associated with this position must consider the long-term durability of the design.

Efficacy - all tasks associated with this position must take into account the device's final application.

Perform other related duties as assigned by the supervisor.

KNOWLEDGE, SKILLS, ABILITIES:
What competencies are necessary for a person in this position?
Knowledge of the U.S.

FDA Quality System Regulation, 21 CFR Part 820 (QSR), along with familiarity with international quality system standards, ISO 13485, ISO 9001.

Evaluate electronic component data sheets and characteristics for their relevance to specific circuit applications.

Enhance and develop departmental processes related to component selection and qualification.

Must exhibit attention to detail with high accuracy.

Must be capable of understanding and operating advanced testing equipment.

Must possess excellent verbal and written communication skills.

EDUCATION AND EXPERIENCE:
What is the typical educational background and work experience of an individual qualified for this role?

Bachelor of Science degree or Master of Science degree, with a minimum of 8 years of experience in electronics design and analysis of both analog and digital circuits.

Additionally, a minimum of 10 years' experience in component engineering.

Familiarity with design aspects of image sensors, FPGAs, microprocessors, and memory is preferred.

Experience and knowledge of video systems and CCD and CMOS imager technology is advantageous.

Familiarity with Endoscopy in a Medical Device company is a plus.

PHYSICAL & MENTAL REQUIREMENTS:
What are the specific physical and mental demands of this position?
Visual acuity sufficient for testing.

Ability to remain seated for extended periods (during meetings and computer work).

Ability to lift video and testing equipment (approximately 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.

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