Senior Systems Engineer

Universal Diagnostics; United States; On-site; USD 120,000 - 160,000; Full time

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

Skills

Systems engineering

Requirements analysis

Risk management

Regulatory compliance

Traceability management

Education

Engineering/CS/Bioinformatics degree

Tools

Polarion

Jama Connect

IBM DOORS

Job description

About our Company:

Universal DX, Inc. is an international Company with a highly experienced team focused on cracking cancer's code. Through our multi-omics and bioinformatics models, we have figured out how to read the disease's signals in blood with high accuracy to detect cancer in its earliest stages. Starting with a colorectal cancer screening liquid biopsy test, we are building a multi-cancer platform that can identify the unique DNA regions associated with different types of cancers.

The Opportunity:

Universal DX, Inc is seeking an experienced Senior Systems Engineer to join our growing team. In this role, you will work directly with the Director of Software Lifecycle and Compliance and play a critical role in supporting the development of next-generation bioinformatics, computational biology, and laboratory automation software in compliance with IEC 62304, ISO 14971, FDA design controls, and Computer System Validation (CSV)/Computer Software Assurance (CSA) expectations for Class III (PMA) medical devices and IVD systems.

You will contribute as a senior technical individual contributor responsible for systems engineering activities across assigned systems and workstreams, including requirements development, interface definition, risk management, verification planning, test development and execution, and lifecycle traceability.

You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers. As part of the team, you will be in a Company that aims more than to become one of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of “making cancer a curable disease by detecting it earlier”.

How you'll contribute:

Systems and Requirements Engineering

Independently develop, refine, review, and maintain software and system requirements for regulated IVD software, bioinformatics pipelines, computational biology platforms, laboratory automation systems, and supporting validated software tools in alignment with IEC 62304 and FDA expectations for Class III medical devices

• Ensure end-to-end traceability
• Risk Management
• Computer System Validation (CSV) & Compliance Support
• Cross-Functional Collaboration
• Verification & Compliance Support
• Tools & Process Support

What you'll bring:

Required Qualifications

• Bachelor’s, Master’s, or Ph.D. degree in Engineering, Computer Science, Bioinformatics, Computational Biology, Biology, or a related technical discipline
• 3+ years of experience creating and managing software requirements for Class III (PMA) medical device software or regulated IVD systems
• 5+ years of experience in software requirements analysis, systems engineering, business analysis, software compliance, or related healthcare software development activities
• Experience with IEC 62304 software lifecycle processes and FDA design controls for medical device software
• Experience creating and managing risk management activities aligned with ISO 14971
• Experience supporting Computer System Validation (CSV) and/or Computer Software Assurance (CSA) activities in regulated healthcare, laboratory, or medical device environments
• Prior experience supporting bioinformatics pipelines, computational biology software, laboratory automation workflows, or validated laboratory software systems in a regulated environment
• Experience collaborating cross-functionally with software engineers, computational biologists, automation engineers, QA, V&V, and R&D stakeholders
• Strong technical writing, analytical, and traceability management skills

Preferred Qualifications

• Prior experience supporting PMA submissions or FDA regulatory inspections
• Experience with In Vitro Diagnostic (IVD) medical devices and CLIA laboratory environments
• Familiarity with 21 CFR Part 11 and data integrity expectations for validated software systems
• Experience with requirements management and traceability tools such as Polarion, Jama Connect, or IBM DOORS
• Familiarity with laboratory automation workflows, sequencing pipelines, or NGS-based diagnostic systems
• Understanding of software verification and validation methodologies in regulated environments
• Ability to rapidly learn and support new technical domains and software functionality

What we´ll offer:

• 22 days of PTO with the possibility to carry over 10 days to the following year.
• Company Holidays, plus your Birthday off!
• Company-sponsored benefit plans, including medical, dental, and vision insurance plus life, STD, and LTD coverage, and 401(k).
• Flexible work schedule
• And more to come!

Why Now?

This is an exciting time to be at Universal DX. We are growing rapidly and starting our US operations by building up our team, starting our lab and business operations, and establishing strategic partnerships.

We are looking for passionate changemakers to be a part of our journey in this expansive time for us.