Senior Systems Engineer - Regulated IVD & Bioinformatics

Universal Diagnostics

United States

On-site

USD 120,000 - 160,000

Full time

5 days ago

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Benefits offered by this job

PTO 22 days + 10 carryover

Holiday and Birthday off

Medical, dental, vision insurance

Life, STD, LTD insurance

401(k)

Flexible work schedule

Job summary

Universal DX, Inc is seeking an experienced Senior Systems Engineer to support the development of regulated IVD software, bioinformatics pipelines, and laboratory automation systems in compliance with IEC 62304, FDA design controls, and ISO 14971 risk management. You will work with cross-functional teams to ensure lifecycle traceability and validation across projects.

You will contribute as a senior technical individual contributor handling requirements development, risk management, verification

Qualifications

3+ years creating and managing software requirements for Class III (PMA) medical device software or regulated IVD systems
5+ years in software requirements analysis, systems engineering, or related healthcare software development activities
Experience with IEC 62304 software lifecycle processes and FDA design controls for medical device software
Experience with ISO 14971 risk management activities
Experience CSV/CSA activities in regulated healthcare environments with validated software systems

Responsibilities

Develop and maintain software and system requirements for regulated IVD software, bioinformatics pipelines, computational biology platforms, and laboratory automation systems
Ensure end-to-end traceability across all workstreams and systems
Support CSV/CSA activities and ensure regulatory compliance across development lifecycles
Collaborate cross-functionally with software engineers, QA, R&D, and automation teams