Senior Systems Analyst (DOORS Next Gen) - Blue Star Partners LLC

Job Title: Senior Systems Analyst

Location: Remote (Pacific Time Zone)

Rate: $62 - $65/hr

Duration: 1 Year with possible extension

Contract Type: W2 (must be authorized to work in the US; no sponsorships or 1099)

Job Description

The Senior Systems Analyst is responsible for leading the implementation and configuration of IBM Rational SaaS systems, specifically DOORS Next Gen (DNG) and Engineering Test Management (ETM). This role requires hands-on technical expertise, project management skills, and the ability to collaborate effectively with subject matter experts (SMEs). The position is remote but will primarily operate on Pacific Time Zone hours.

This role focuses on optimizing system performance, ensuring compliance, and supporting strategic business initiatives through effective configuration and management of IBM Rational systems.

Key Responsibilities

• Configure and implement IBM Rational DOORS Next Gen (DNG) and Engineering Test Management (ETM) systems.
• Lead project management activities, ensuring on-time and efficient delivery of solutions.
• Collaborate with stakeholders and SMEs to implement best practices in medical device product development using IBM systems.
• Refine conceptual system requirements into actionable technical designs, job flows, and program specifications.
• Provide performance optimization, maintenance, and production support for IBM systems.
• Develop, test, and implement cost-effective application solutions.
• Understand and translate customer business objectives into technical requirements, ensuring alignment with strategic goals.
• Facilitate system configuration responsibilities, effectively setting options to meet customer and organizational needs.
• Lead implementation activities, coordinate cross-functional teams, and provide updates to project management.
• Ensure compliance with applicable corporate policies, including medical device computer system validation and 21 CFR Part 11 requirements (preferred).

Required Qualifications

• Experience: Minimum of 5 years of experience configuring and implementing DOORS Next Gen (DNG) and Engineering Test Management (ETM) systems (strong preference for 10+ years).
  • Must have DOORS Next Gen expertise (DOORS Classic experience is not sufficient).
• Project Management: Demonstrated experience managing projects and coordinating with SMEs.
• Technical Skills: Some administrative experience with IBM Rational SaaS systems.
• Education: Bachelor’s degree is preferred

Preferred Qualifications

• Experience in medical device product development, including knowledge of computer system validation and 21 CFR Part 11 requirements.
• Strong understanding of best practices in medical device system implementations.
• At least 5 years of experience configuring DOORS Next Gen (DNG) and Engineering Test Management (ETM) systems.
• Some administrative experience with IBM systems.
• Proven project management experience.