What are the responsibilities and job description for the Systems Engineer - Onsite position at Viva USA Inc.?
Title : Systems Engineer - Onsite
Are you the right applicant for this opportunity Find out by reading through the role overview below.
Description :
The Systems Engineer will be accountable for delivering systems engineering tasks for significant portions of Sustaining programs including integration of mobile systems, wireless technologies into medical devices. Working in client site, the primary responsibilities include systems integration, formal verification, following design change control process, including supporting in-market products. The individual will be expected to provide hands-on execution and work with other team members from a wide range of functions and / or geographical locations. Communicates with the other engineering personnel to coordinate the interrelated design and assure project completion.
RESPONSIBILITIES :
Plans, manages, and reports on overall systems integration.
Generates / Supports the systems integration plan and report.
Coordinates system engineering testing to verify systems functionality including software.
Drives and records configuration of system at integration points.
Supports system design change control process.
Leads / Executes system verification execution.
Identifies and escalates risks in terms on systems viability with existing requirements.
Evaluates / analyzes requirements for coherence and completeness and clarifies ambiguous requirements.
Ensures tracing from requirements to test. Working experience with Requirements Managements tools e.g., DOORS, JIRA etc.; use and administration of DOORS a plus.
Experience in understanding medical device standards (62304, 60601, etc.) a plus
May support Internal and External Audits, as directed by management.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Anticipated business travel around 10%.
EDUCATION AND EXPERIENCE :
Required :
Bachelor’s degree in engineering and / or Science with 1 year of experience in developing highly engineered products (at least 1 year in medical / diagnostics products), or an equivalent combination of education and experience.
Possesses systems engineering experience spanning the entire product lifecycle, including proficient use of systems engineering tools (e.g. requirements management, change control, etc.).
Systems engineering experience in a highly regulated industry
Excellent verbal and written communication skills, with ability to communicate effectively to Core Team.
Previous experience working in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Preferred :
Master’s degree in engineering (Computer, Electrical, Mechanical, Computer Systems, or Software), Computer Science, or related discipline.
Medical device experience, specifically supporting the client and / or cardiovascular systems and experience with biologic sensors (flow, pressure, EKG, etc).
Mandatory skills : Pharmaceutical,,
medical products, diagnostics products,
systems engineering, product lifecycle, requirements management, change control,
heart failure systems, cardiovascular systems,
medical device components, single system, wired technologies, wireless technologies, systems integration, formal verification, verification plan,
design change control process, on-market products
VIVA USA is an equal opportunity employer and is committed to maintaining a professional working environment that is free from discrimination and unlawful harassment. The Management, contractors, and staff of VIVA USA shall respect others without regard to race, sex, religion, age, color, creed, national or ethnic origin, physical, mental or sensory disability, marital status, sexual orientation, or status as a Vietnam-era, recently separated veteran, Active war time or campaign badge veteran, Armed forces service medal veteran, or disabled veteran. Please contact us at hr@viva-it.com for any complaints, comments and suggestions.
Contact Details :
Account co-ordinator : Dinesh Kumar U, Phone No : (847) 461-3640, Email : staffing10@viva-it.com
VIVA USA INC.
3601 Algonquin Road, Suite 425
Rolling Meadows, IL 60008
staffing10@viva-it.com | http : / / www.viva-it.com
