Systems Engineer

About Us: Artera is an AI startup that develops medical artificial intelligence tests to personalize therapy for cancer patients. Artera is on a mission to personalize medical decisions for patients and physicians on a global scale.

We are seeking a Systems Engineer to lead the requirements, risk management, system architecture, and usability engineering activities across the product lifecycle. This role is critical in ensuring our products are safe, effective, and compliant with regulatory requirements while enabling cross-functional teams to collaborate effectively. The Systems Engineer will act as the owner of requirements traceability, system architecture documentation, and usability testing, driving high-quality engineering practices that ensure regulatory success and market readiness.

• Requirements Engineering:

• Drive a high-quality, traceable requirements process across product and software teams.
• Ensure requirements are necessary, unambiguous, testable, verifiable, and avoid premature design decisions.
• Establish and maintain traceability between product requirements, software requirements, and verification/validation activities.
• Develop systems and tools for requirements traceability to make information accessible and understandable to cross-functional teams.

• Software Risk Management:
• Lead software risk management activities from development through post-market surveillance.
• Perform hazard analysis, risk classification, identification of risk controls, and documentation of risk management activities.
• Ensure traceability and verification of implemented risk controls.
• Manage risk during product changes and in post-market surveillance by assessing software changes, legacy systems, and problem reports, implementing appropriate mitigation activities.

• System Architecture Documentation:
• Create and maintain QMS software design documentation, ensuring clarity and regulatory alignment.
• Define and maintain system diagrams and interface documentation that accurately reflect system behavior and component interactions.

• Usability Engineering:
• Plan and execute usability testing activities, including formative and summative studies.
• Evaluate user interfaces and develop usability evaluation plans.
• Conduct usability studies, observe user performance, and document findings.
• Manage the usability engineering file and ensure integration with risk management and requirements.

• Regulatory & Quality Support:
• Author and review regulatory submission sections pertaining to system architecture, usability, risk management, and verification/validation.
• Support responses to regulatory questions with clear technical and design rationale.
• Ensure regulatory submissions are coordinated and consistent with QMS documentation.
• Support continuous improvement of the Quality Management System, particularly around requirements traceability, usability, and risk management.
• Assess system-wide impact of changes on requirements, risks, usability, and regulatory compliance.

• Required:
• Bachelor’s degree in Computer Science, Electrical Engineering, Biomedical Engineering, or related field.
• 5+ years of experience in systems engineering for regulated medical devices or software as a medical device (SaMD).
• Strong knowledge of FDA, EU MDR, and ISO regulations, including IEC 62304, ISO 14971, IEC 62366, and ISO 13485.
• Demonstrated expertise in requirements management, traceability, and risk management.
• Experience conducting usability engineering in compliance with IEC 62366.
• Excellent technical writing and documentation skills, particularly for regulatory submissions.
• Familiarity with requirements management tools .
• Strong cross-functional collaboration skills, with the ability to communicate clearly with engineering, quality, regulatory, and clinical teams.
• Systems thinking mindset with the ability to manage complexity across hardware, software, and user workflows.
• Understands and complies with ethical, legal, and regulatory requirements applicable to the medical device industry. 
• Effective leadership, management, and teamwork skills.
• Strong written and verbal communication skills; proactive cross-functional communicator.
• Ability to work independently with minimal oversight and direction.
• Ability to effectively manage and prioritize multiple tasks and projects.
• Flexibility and adaptability to work in a dynamic and rapidly changing start-up environment.
• Strong desire and vision to build a new organization with a clear vision.

• Preferred:
• Experience with digital health, AI/ML, or diagnostic, or software devices.
• Experience supporting FDA or international regulatory submissions.

• Expected Travel: <5% domestic

Equal Employee Opportunity: At Artera, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients and physicians. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.