V&V Engineer- Medical Device

Inspira™ Technologies is an innovative medical technology company in the Life Support arena.

The Company has developed a breakthrough Augmented Respiration Technology (INSPIRA™ ART), with adaptive blood monitoring and blood oxygenation technology designed to rebalance patient oxygen saturation levels.

This technology allows patients to remain awake during treatment while reducing the need for highly invasive, risky, and costly mechanical ventilation systems requiring intubation and medically induced coma—equipped with HYLA™ real-time continuous blood monitoring technology.

The system instantly detects patient condition changes, empowering physicians to make informed decisions.

We are looking for an experienced Medical Device V&V Engineer to join our team. The ideal candidate will have extensive experience in planning, executing, and managing the V&V process for medical devices, and will work closely with R&D, QA, and regulatory teams to ensure product quality and compliance.

Duties & Responsibilities:

Define and establish V&V testing methodologies and coverage for medical device systems.
Collaborate closely with R&D, QA, and regulatory teams to ensure the device meets design requirements and complies with relevant standards.
Develop, write, and execute V&V protocols and reports for the device lifecycle.
Plan and execute V&V tests for the full system, including hardware, software, and mechanical components.
Perform safety validation activities at third-party facilities to ensure compliance with applicable standards (EMC, Safety).
Support risk management activities, identifying, tracking, and resolving issues throughout the product lifecycle.
Ensure the product complies with industry regulations. (ISO 13485, FDA, etc.) and relevant quality management systems (QMS).

Requirements:

Biomedical Engineering / Biotechnology /Mechanical Engineering or another related field is a plus.
Significant experience in V&V in a medical device.
Hands-on experience working with multi-disciplinary systems (hardware, software, mechanical).
Excellent technical writing skills in both English and Hebrew.
Experience in clean room production environment- advantage
Familiarity with ISO 13485 and experience working in a QMS environment is a significant advantage.
Strong problem-solving skills and attention to detail.
·Ability to work independently as well as part of a multidisciplinary team.