Senior Requirements Engineer – Regulated Medical Software

Universal Diagnostics S.A.; Dallas (TX); On-site; USD 100,000 - 140,000; Full time

Benefits offered by this job

22 days of PTO with carryover

Company holidays and birthday off

Company-sponsored medical, dental, and vision insurance

401(k) plan

Flexible work schedule

Job summary

Universal Diagnostics S.A. is hiring a Senior Software Requirements Engineer in Dallas, TX to develop and manage software requirements for regulated IVD systems. You'll work with the Sr. Director of Software Lifecycle and Compliance, ensuring compliance with industry regulations like IEC 62304 and FDA standards.

This role demands strong skills in risk management, traceability, and cross-functional collaboration with biology, software, and quality assurance teams. Join a company dedicated to making cancer a curable disease through early detection technologies and innovative software solutions.

Qualifications

• 3+ years of experience creating and managing software requirements for Class III medical device software.
• 5+ years of experience in software requirements analysis, systems engineering, business analysis, or related healthcare software development activities.
• Experience with IEC 62304 software lifecycle processes and FDA design controls.

Responsibilities

• Develop and maintain software and system requirements for regulated IVD software.
• Ensure end-to-end traceability and support risk management activities.
• Work with software engineers and QA on compliance support.

Skills

Software requirements analysis

Risk management

Technical writing

Cross-functional collaboration

Education

Bachelor’s, Master’s, or Ph.D. in Engineering, Computer Science, Bioinformatics, Computational Biology, Biology, or related discipline

Tools

Polarion

Jama Connect

IBM DOORS

Job description

Universal Diagnostics S.A. is hiring a Senior Software Requirements Engineer in Dallas, TX to develop and manage software requirements for regulated IVD systems. You'll work with the Sr. Director of Software Lifecycle and Compliance, ensuring compliance with industry regulations like IEC 62304 and FDA standards.

This role demands strong skills in risk management, traceability, and cross-functional collaboration with biology, software, and quality assurance teams. Join a company dedicated to making cancer a curable disease through early detection technologies and innovative software solutions.