Senior Software Requirements Engineer – Regulated Medical Devices

Universal Diagnostics; United States; Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

22 days PTO with possibility to carry over 10 days

Flexible work schedule

Company-sponsored benefit plans including medical, dental, vision insurance

Job summary

Universal Diagnostics is seeking a Senior Software Requirements Engineer to support the development of innovative software solutions for early cancer detection technologies. You will work in a collaborative environment, ensuring regulatory compliance with IEC standards and FDA design controls, addressing critical responsibilities in software requirements engineering.

The ideal candidate has demonstrated expertise in managing software requirements for Class III medical devices, and will play a vital role in our mission to detect cancer at its earliest stages.

Qualifications

• 3+ years in managing software requirements for Class III medical devices.
• 5+ years in software requirements analysis or related activities.
• Experience with IEC 62304 and FDA design controls.
• Experience supporting risk management aligned with ISO 14971.
• Experience in Computer System Validation (CSV) or Computer Software Assurance (CSA).

Responsibilities

• Develop and maintain software and system requirements for regulated IVD software.
• Ensure end-to-end traceability and compliance with software lifecycle expectations.
• Support risk management activities with QA and cross-functional teams.
• Collaborate on Computer System Validation and compliance documentation.
• Participate in inspection support activities for regulated environments.

Skills

Software requirements analysis

Regulatory compliance

Traceability management

Risk management

Technical writing

Education

Bachelor's, Master’s, or Ph.D. in Engineering, Computer Science, Bioinformatics or related

Tools

Requirements management tools (Polarion, Jama Connect, IBM DOORS)

Job description

Universal Diagnostics is seeking a Senior Software Requirements Engineer to support the development of innovative software solutions for early cancer detection technologies. You will work in a collaborative environment, ensuring regulatory compliance with IEC standards and FDA design controls, addressing critical responsibilities in software requirements engineering.

The ideal candidate has demonstrated expertise in managing software requirements for Class III medical devices, and will play a vital role in our mission to detect cancer at its earliest stages.