Systems Engineer IV

Systems Engineer IV

Charlton, MA, US, 01507

JOB SUMMARY:

Responsible for product design at system level. He/she works closely together 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.

POSITION FUNCTIONS:

System Design

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.

Ensure that all authors (including the Systems Engineer) of separate design specifications have articulated the specifications in enough detail to design a system that meets all defined and approved product requirements.

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, optical, and mechanical design specifications.

Participate in the system risk analysis.

Assist in defining Essential Performance

Define network and insulation diagram.

Participate in creation of technical system documentation.

Track and review the detailed hardware, software, optical, 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 Compliance Engineer 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)

Collaborate with project management in Agile Development activities.

Analyses and Modeling

Perform system analysis and modeling to support tradeoff studies as required.

Develop means (tests) of analyzing system components to objectively quantify performance.

Determine methods of communicating the analytical results with the rest of the Engineering staff.

Determine, where appropriate, empirical methods, to validate analytical models. If necessary, update the model assumptions and/or empirical methods to correlate the results.

Document the results of the analyses in technical reports.

Research and Development

Research and develop new technology for use in future and existing OR1 products.

Communicate with purchasing and vendors for new processes and capabilities required for new designs.

Sustaining Support

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.

General Engineering

Provide support and technical direction for the generation and maintenance of the system Design Assurance Checks.

Regular attendance is an essential job function.

Will spend part of his/her time as a member of continuous improvement teams undertaking projects and seeking ways to improve the quality of products and services.

ADDITIONAL RESPONSIBILITIES:

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.

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, ABILITITES:

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.

Ability to perform system tradeoff studies.

Experience with video systems

Knowledgeable of image processing techniques

Solid understanding of software design methodology and deliverables

Understanding of networks (protocols, topologies, etc.)

Thorough understanding of microprocessor-controlled systems

Broad understanding of analog and digital hardware design.

General understanding of optical design, optical materials, and coatings

General understanding of mechanical issues including adhesives, sealing techniques and sterilization requirements

Expert level skills in documenting and communicating system design deliverables and drawings.

Highly desirable to have medical systems product design experience.

EDUCATION AND EXPERIENCE:

BS / Masters / PHD degree in Electrical Engineering, Physics, Electrical Computer Engineering, Computer Science plus 9+ years industry experience followed with 5+ years in the role of Systems Engineer.

PHYSICAL & MENTAL REQUIREMENTS:

Visual acuity sufficient for testing

Ability to sit for extended periods (during meetings and computer work)

Ability to lift video equipment.

Ability to connect electrical devices.

TRAINING REQUIREMNTS:

Injury and Illness Prevention Program

Quality System training

Job Specific - In house requirement

LEVEL OF SUPERVISION REQUIRED:

The department manager develops general goals for the employee at the yearly review cycles, which are derived from the overall company goals.

Tasks are derived from these general goals by the employee and reviewed and accepted by the department manager.

Detail peer review of work accomplished is required and scheduled as required.

INTERFACE:

Product management to understand the end user requirements.

Project Engineers and Project Managers for system design and tradeoff studies

Manufacturing Engineers for manufacturability issues

Interact with KARL STORZ departments globally.

KARL STORZ is committed to maintaining a safe work environment for our employees and customers. Most field-based roles at KARL STORZ require hospital credentialing/health screens as a condition of employment. Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers. During the interview process, we encourage you to ask how credentialing/health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.

The pay range and/or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future. When determining a specific team member’s base salary and/or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.

KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences. To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status, or any other protected characteristic. KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at taoperations@karlstorz.com.

Nearest Major Market: Worcester