System V&V Engineer

About us

At Theranica Bio-Electronics, we are at the forefront of developing innovative, wearable treatments for migraine and other pain conditions, merging cutting-edge technology with patient-centered care. Our goal is to translate our technological and business knowledge in mobile digital solutions to the field of pain therapeutics.

We offer non-invasive, drug-free, personalized, and affordable wearable therapeutic products for the treatment of pain by integrating the latest neuroscience research with notable technological expertise.

Our collaborative and dynamic work environment fosters creativity and growth, encouraging our team to push the boundaries of medical science. By joining us, you'll be part of a passionate group dedicated to improving lives through pioneering health solutions.

Job Brief

We are seeking a highly motivated System V&V Engineer to join our Quality Assurance team. The ideal candidate will be responsible for planning and executing system-level verification and validation activities for a complex product ecosystem that includes hardware, embedded software, and mobile applications.

You will play a critical role in ensuring that our products meet regulatory, quality, and user requirements, delivering safe and effective solutions to patients worldwide.

Responsibilities and Authorities

Responsibilities

• Develop and execute system-level V&V strategies, plans, and protocols aligned with regulatory requirements (FDA, MDR, ISO standards).
• Participate in design reviews, risk management activities (FMEA), and requirement discussions.
• Generate and review test documentation, including V&V plans, protocols, reports, and Traceability matrices.
• Support root cause analysis and troubleshooting of system-level issues.
• Support user validation and usability testing aligned with intended use conditions.
• Ensure validation activities demonstrate compliance with user needs and intended use.
• Work closely with Product, Engineering, R&D, Clinical and QA teams to perform end-to-end testing across HW, firmware, and mobile apps.

Authorities

• Define and recommend system V&V approaches, methodologies, and test coverage.
• Approve execution readiness of test protocols and test environments.
• Escalate gaps in requirements or testability affecting product quality.
• Stop releases (in alignment with QA governance) if critical quality, safety, or compliance risks are identified.
• Sign off on verification completion for assigned modules or system scopes.
• Ensure adherence to regulatory and internal quality standards.
• Drive defect prioritization discussions with development teams.
• Recommend risk mitigation actions based on test results and system behavior.
• Provide formal input into design reviews, requirement reviews, and risk assessments (FMEA).
• Advocate for testability, reliability, and user safety throughout development.
• Influence timelines based on verification readiness and quality status.

Qualifications & Requirements

Must Have

• Bachelor’s degree (B.Sc.) in: Mechanical Engineering, Electrical/Electronics Engineering, Industrial Engineering / Engineering Management, or a related discipline.
• 3–5 years of experience in system verification & validation, QA, or testing within the medical devices industry.
• Experience with design controls, risk management, and validation processes.
• Strong understanding of system-level testing methodologies.
• Ability to work independently and collaboratively across multiple disciplines.
• Hebrew – working proficiency.
• Technical English – ability to read technical terms and standard requirements.

Nice to Have

• Experience with integrated systems (HW + firmware + mobile/software).
• Strong analytical and problem-solving skills.
• Excellent communication and documentation abilities in a global environment.
• Detail-oriented with a strong commitment to quality and compliance.
• Usability / human factors validation knowledge.

Work environment

• Hybrid.