Sr. Systems Analyst

• 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.
• 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.
• If Do Not Have Doors Next Gen Experience, Do Not Submit.
• 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.

Required:

• Bachelor Degree/4-7years experience

We are seeking a highly skilled DOORS Administrator with the following key responsibilities:

• Manage the IBM Rational DOORS requirements database for various programs.
• Import documents from various source files and create/populate attributes.
• Create and maintain link modules and link sets for traceability, verification, and analysis.
• Manage access to the DOORS database.
• Lock documents down for change control, propose changes, review the effectivity of proposed changes, and export change notices.
• Hold reviews, approve, and incorporate approved changes in the database.
• Provide frequent input, guidance, and training to the program’s DOORS users to enable efficient usage of the DOORS tool.
• Generate reports out of DOORS for program status.
• Perform product definition, system architecture, requirements writing, requirements management, requirements analysis, risk analysis, hazard analysis, product test and evaluation, System V & V, and/or design control documentation. 
• Evaluate unique program situations to develop tailored DOORS approaches.

DOORS Next Gen (DNG) – Must have experience managing the system, not just configuring it

ETM (Engineering Test Management) – experience in Configuration

Experience with IBM tools integration

Comfortable working in Windows and Linux environments

Additional qualifications:

• Bachelor’s degree in computer science, Information Technology, Systems Engineering, or a related field.
•  3+ years of experience with IBM DOORS, including administration and database management.
• Strong knowledge of requirements management and systems engineering processes.
• Proficient in DXL scripting and custom reporting.
• Excellent problem-solving and analytical skills.
• Strong communication and teamwork abilities.
• Ability to work independently and manage multiple tasks simultaneously.
• Responsible For Configuration Of IBM Rationale Saas Systems, Specifically DOORS Next Gen (DNG) And Engineering Test Management (ETM)