Systems Integration Engineer NeuroVista

Systems Integration Engineer ? Temporary, Full-time

The Systems Integration Engineer, under the direction of the Principal Systems Engineer, works with engineering management and other team members to help create and manage design artifacts; e.g., user needs, product requirements, risk analyses, etc.



Primary Responsibilities

Work with engineering project managers to develop and review product requirements for systems and individual devices. This encompasses all aspects of the product including hardware, software, packaging, labeling, user interface, etc. Work to ensure that specified requirements are clear, verifiable, self-consistent, and appropriately address user needs and the applicable external standards and regulations.
Work with marketing, clinical research, and engineering project managers to develop and review use cases that appropriately reflect user needs and how users will interact with the product.
Work with engineering project managers and other team members to develop and maintain top-down risk analyses. Provide assistance to product teams on related documents, such as design FMECAs and process FMEAs.
Participate in the planning, review, conduct, and reporting on system integration testing, including system level design qualification activities. This may include the investigation and resolution of system level product issues.
Support Quality Engineering in the planning and development of design verification and design validation deliverables.
Provide timely support for project teams. Provide status updates as required.



Required Education, Skills and Experience

5+ years experience in formal/ regulated environment
Working knowledge of ISO 13485, ISO 14971, EN 60601-X, EN 45502-X, IEC 62366
Proficient with engineering processes and procedures throughout the product life cycle
Wide application of technical principles, practices, and procedures
Experience with requirements management, design verification, and design validation
Experience in cross-functional teams on product development
Organized with strong analytical and problem solving skills
Strong, effective presentation and interpersonal skills
Superior writing, grammatical, and composition skills necessary
Excellent Microsoft Office skills, especially Visio, WORD, Excel and PowerPoint
Familiarity with typical electronics laboratory equipment



Other Qualifications

Proven record of consistently following through on commitments.
Team focused, collaborative, self-motivated and passionate for innovation and high quality work.
Must be able to work effectively in an entrepreneurial, informal developmental environment, yet deal effectively with external regulatory constraints and internal schedule, manpower and budgetary constraints.
Demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside the Company.

Location:	100 Fourth Avenue North Suite 600 Seattle, WA 98109 United States