System Analyst

EPITEC; Illinois; Remote; USD 135,000 - 175,000; Full time

Job summary

A leading company in the medical equipment manufacturing industry is seeking a Mid-Senior level Information Technology Specialist to configure IBM Rationale SaaS systems like DOORS Next Gen and ETM. The ideal candidate will have significant experience in medical device product development and will take on responsibilities in project management and user training, ensuring efficient system functionality. This remote position focuses on the Pacific Time Zone and requires at least a high school diploma.

Qualifications

• Minimum 5 years’ experience required, preferably over 10 years.
• Experience in DOORS Next Gen and ETM configuration and implementation.
• Medical device experience is a plus.

Responsibilities

• Implement and configure IBM DOORS Next Gen and ETM systems.
• Manage project and collaborate with SMEs.
• Provide training and generate reports from DOORS.

Skills

Configuration of DOORS Next Gen

Project Management

Medical Device Development Best Practices

Requirements Writing

Education

High school diploma

Job description

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• Position is Remote but will mainly be working on Pacific Time Zone.

Responsibilities:

• Responsible for configuration of IBM Rationale SaaS systems, specifically DOORS Next Gen (DNG) and Engineering Test Management (ETM); leading implementation and configuration those systems.
• Doing project management and working cooperatively with subject matter experts (SMEs).
• Maintain knowledge and implementation of best practices of medical device product development utilizing the specific IBM systems.
• Will be implementing and configuring the system with stakeholders.
• 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.

Experience Required:

• 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.

Other preferred skills:

• Nice to have additional expertise in medical devices computer systems validation and 21 CFR Part 11 requirements.
• Medical device experience preferred but not required.

Top Three Skills:

• Minimum 5 years' experience configuring DOORS Next Gen and ETM.

Education Required:

• Candidate must at least have a high school diploma to be considered.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Information Technology

• Industries

  Medical Equipment Manufacturing

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