Jama Connect Requirements Specialist

Project Overview

This is a high-visibility, project-critical role dedicated to shaping the future of design controls and risk management within our engineering division. The division is undergoing a major, mandatory transition from a legacy requirements management software (Integrity) to Jama Connect, a modern requirements and risk management tool.

The successful candidate will be the primary driver behind this transformation:

• Architecting the new documentation structure.

• Restructuring design controls and risk management.

• Introducing Systems Engineering practices not yet established in the division.

This position has high visibility and long-term impact as it directly shapes future documentation structure and systems practices. The project scope may extend beyond the initial contract term based on business needs and successful completion of instrumentation documentation.

The responsibilities blend technical expertise, process leadership, and medical device compliance:

• Lead the restructuring and development of new design control and requirements management documentation architecture within the Jama Connect environment.

• Translate legacy requirements from the Integrity system to the new structure, facilitating a consolidated, systems-based approach.

• Develop architecture documents and use cases to help establish requirement tiering and comprehensive trace matrices for design verification and validation.

• Analyze mechanical (metal/plastic) instrument and implant systems from a documentation perspective to ensure compliance.

• Actively apply and integrate systems engineering techniques, including architecture modeling, model-based system languages (MBSE/SysML), trade studies, simulation, and budgeting.

• Contribute to design decomposition and risk management activities (per ISO 14971) within the new Jama framework.

• Assist in migrating data from the Integrity platform to Jama Connect (data manipulation required; no system integration work).

• Collaborate effectively with cross-functional stakeholders (R&D, Quality, Regulatory) to define, document, and educate teams on new systems and processes.

• Under minimal supervision, research, develop, modify, and verify engineering documentation, such as the Design History File (DHF), ensuring compliance with R&D procedures and the Quality Management System.

• Demonstrate advanced understanding of customer needs and clinical procedures to effectively translate user needs to system requirements.

• Bachelor of Science in Software, Electrical, Mechanical, Systems, or Biomedical Engineering.

• 2+ years of professional experience in Systems Engineering or Requirements Management.

• Hands-on experience with Requirements Management Tools (RMTs).

• Strong working knowledge of requirement and verification practices.

• Logical and structured thinker with excellent documentation and analytical skills.

• Ability to communicate complex technical plans and information clearly to team members.

• Direct, recent experience with Jama Connect

• Experience with SysML and Model-based Systems Engineering (MBSE).

• Knowledge of regulated industries (Medical Device preferred) and standards such as ISO 13485 and ISO 14971.

• Certifications such as INCOSE ASEP, or equivalent.