Description

You will own the creation, maintenance, and management of system and subsystem requirements for complex medical device projects.

Responsibilities

• Access, create, and revise requirements within the IBM Rational DOORS database.
• Interface with subject matter experts, designers, and stakeholders to define and clarify technical product specifics.
• Manage requirements traceability information and track status throughout the project lifecycle.
• Decompose requirements and maintain hierarchy to ensure proper architectural linkages.
• Use the Rational publishing engine to generate Word documents for design history files.

Required Skills

• 5+ years of experience in requirements management for complex products.
• Proficiency in IBM Rational DOORS for creating, modifying, and reviewing structured data.
• Experience working within an Agile development framework.
• Strong understanding of requirements elicitation, analysis, specification, verification, and management practices.
• Ability to manage requirements traceability and report on link relationships within a database.
• Analytical skills to evaluate information from multiple sources and develop optimized requirements.
• Effective communication and negotiation skills to resolve conflicts among stakeholders.
• Any Graduate degree.

Preferred Skills

• Knowledge of FDA Design Control regulations and associated standards.
• Experience with medical diagnostic devices or analyzers.

Key Skills

Education

Any Graduate