The Opportunity:

Universal DX is seeking an experienced System Engineer II to join our growing team. You will work directly with the Sr. Director of Production Engineering and will play an integral role in contributing towards the Company’s future growth by leading and ensuring that the next generation of Universal DX’s automation tools and pipeline software are robust, scalable, and aligned with security best practices.

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:

• Collaborate with cross-functional teams to elicit, identify and refine user needs for our internal software tools and platforms.

• Translate stakeholder needs into well-defined, prioritized user stories or system requirements.

• Maintain and own the product backlog, ensuring clarity, completeness, and alignment with business and regulatory priorities.

• Works closely with the software development team throughout the development process, acting as the voice of the customers to resolve product uncertainties as they arise.

• Define user acceptance criteria for all user stories/system requirements.

• Ensure all requirements are traceable, testable, and aligned with regulatory standards (e.g. ISO 13485).

• Maintain and update requirements traceability matrices throughout the development and validation lifecycle.

• Participate in change control processes related to system and software requirements of internal software tools and platforms.

• Develop and lead execution of the CSV strategy in accordance with FDA, GxP, and ISO 13485 standards.

• Prepare CSV deliverables including validation plans, requirements specifications, risk assessments, test protocols, and validation summary reports.

• Conduct risk analysis to identify scope of requirements and testing required by CSV.

• Execute test protocols and manage the deviation process with the software development team.

• Serve as validation subject matter expert during internal and external audits.

• Provide input into design reviews and change impact asessments from a validation perspective.

What you’ll bring:

• Minimum bachelors degree in Engineering, Life Sciences, Bio-Medical or other job-related field.

• 3-5 years of experience in requirements, verification, and validation roles within the biotech, pharmaceutical, or medical device industries.

• 2+ years of experience in an Agile/Scrum development environment, preferably as a Product Owner or similar role.

• Strong understanding of regulatory standards (e.g., FDA 21 CFR Part 11, ISO 13485, IEC 62304).

• Strong understanding of risk management methodologies (e.g., FMEA, hazard analysis).

• Strong understanding of requirements, test case, and traceability management within a regulated change control processes.

• Excellent communication and interpersonal skills to interface with stakeholders at all levels, particularly management and above.

• Strong analytical and problem solving skills, with an ability to quickly identify and escalate core issues.

• Detail-oriented, self-motivated, and able to work independently in a fast-paced, dynamic environment.

• Proficient in one or more requirements management tools (e.g., JAMA, Polarion).

What we´ll offer:

We’re proud to offer exceptional corporate benefits which include:

• Flexible work schedule

• 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 which include Paid Time Off, Medical, Dental, Vision, 401(k)

• And more to come...