Overview
Skills
Job Details
Title: Sr. Systems Analyst - Remote
Mandatory skills:
DOORS Next Gen, ETM, DNG, Engineering Test Management, DOORS Classic,
Admin,
Project Management,
IBM Rationale SaaS systems, IBM systems,
medical device product development, medical devices computer systems validation,
21 CFR Part 11 requirement,
application systems requirements, application system specifications, application solutions,
maintenance, production support, conceptual system requirements, job flows, program specifications,
systems development process, systems development, system requirements, system performance optimization,
SAP
Description:
The Sr. Systems Analyst defines, plans & designs client area application systems requirements for new or modified applications, in the preparation of application system specifications, and in the development, testing, and implementation of efficient, cost effective application solutions.
Duties:
Provide system performance optimization, maintenance and production support. Refine conceptual system requirements into a technical design consisting of job flows and program specifications. Aid in the systems development process, including planning & monitoring systems development efforts, coordinating activities within other groups, reviewing deliverables and communicating to management. Understand customers business objectives and system requirements and work closely with customers to determine their strategic information requirements and measure performance against expectations. Assist in customer resolution. Define implementation activities and assign individual responsibilities; assume leadership role for implementation activities; coordinating implementation with other parts of the enterprise and provide routine status of activities to Project Mgr. or direct supervisor. In specialized systems (i.e.. SAP) effectively set options to change the way the program works (configuration responsibilities). Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Responsible for configuration of IBM Rationale SaaS systems, specifically DOORS Next Gen (DNG) and Engineering Test Management (ETM).
Must have significant experience leading implementation and configuration of those systems.
Including project management, working cooperatively with subject matter experts, knowledge and implementation of best practices of medical device product development utilizing the specific IBM systems.
Nice to have additional expertise in medical devices computer systems validation and 21 CFR Part 11 requirements.
No education requirements other than having at least a high school diploma.
Minimum of 5 years experience but strongly prefer over 10 years.
MUST have DOORS Next Gen (DNG) and Engineering Test Management (ETM) experience with implementation and configuration.
Must be Doors Next Gen exp as will not review DOORS Classic exp.
Will be implementing and configuring the system with stakeholders Must have Project Management exp.
Ability to work with multiple SME (subject matter experts) Med device exp. preferred but not required.
Top 3 skills:
1. Min 5 years exp. configuring DOORS Next Gen and ETM
2. Some Admin exp.
3. Project Management exp.
Required:
Bachelor Degree/4-7years experience
Notes:
Remote from any time zone but will mainly be working with people in the Pacific Time zone so if East Coast, may have to work later
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 for any complaints, comments and suggestions.
Contact Details :
VIVA USA INC.
3601 Algonquin Road, Suite 425
Rolling Meadows, IL 60008