Responsible for product design at system level. Leads collaboration 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 requirements and architectures, and leads system integration efforts, as well as verification reports through the development life cycle.
DUTIES AND RESPONSIBILITIES:
* Derive and maintain ownership of top level system requirements by collaborating with stake holder representatives- Program Management, Manufacturing, Regulatory, Quality Assurance- to understand User Needs * Develop and maintain ownership of system architecture documentation * Perform the necessary tradeoffs (reliability, cost, schedule, manufacturability, etc.) of various design approaches and select an optimal approach * Develop system design specifications, including subsystems and system variations * Make sure that all components are working seamlessly together as one system * Decompose the system (product) requirements into hardware, software, and mechanical design specifications * Participate in the system risk analysis * Assist in defining Essential Performance * Participate in creation of technical system documentation * Track and review the detailed hardware, software, and mechanical design to ensure it meets the objective and requirements identified in the system documents. * Develop and execute plan for integration and test of product components comprising the system * Review system verification plan and system verification procedures * Work with Regulatory to coordinate external system testing with notified body, e.g. T??V, UL, etc. * Ensure traceability between system requirements and verification testing. Responsible for overall system performance * Manage system configurations (configuration management)
* Provide sustaining support for existing product lines.This may include analysis of field issues and/or analysis of manufacturing issues. Recommend, where appropriate, design system changes.
* Documentation of system changes.
* 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 device and where appropriate must consider the long-term durability even after multiple sterilizations and sterilization methods. * Efficacy - all activities associated with this position must consider the devices final application; ergonomics, interaction of the device with the physician, and device operation during usage are all components of efficacy. * Performs other related duties as assigned by supervisor.
KNOWLEDGE, SKILLS, ABILITIES:
* Knowledge of medical device quality system regulations and standards (eg, U.S. FDA Quality System Regulation 21CFR Part 820, ISO13485, ISO9001) * Communicates well with required project contacts, seeks to communicate and form relationships with non-required contacts. * Experience with all of the product development life cycle at Karl Storz or similar industry. * Experience in the design and implementation of complex audio/video systems. * Solid knowledge of audio/visual connectivity and signal flow. * Ability to read wiring diagrams and system design drawings. * < >Ability to produce good documentation & maintain quality controls. * Must be able to work cooperatively with others in a team-oriented environment.
EDUCATION AND EXPERIENCE:
* Bachelor's Degree in Engineering or technology-related field and a minimum of seven years of audio visual technology experience with deep working knowledge of A/V system and equipment; or equivalent combination of education and experience.
* CTS or similar A/V industry certification preferred.
PHYSICAL & MENTAL REQUIREMENTS:
* Ability to sit for extended periods (during meetings or computer work)
* Ability to lift video equipment (approx.20 lbs)
* Ability to work with hand tools during prototype assembly
It is each employee's obligation to consistently treat visitors, external customers and all co-workers with courtesy and respect.