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. TüV, 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.