Medical Device System V&V
Inspira Technologies is an innovative medical device company in the respiratory care industry. Inspira is developing the ART device, a cost-effective early extracorporeal respiratory support system with an intent to function as an “Artificial Lung” for deteriorating respiratory patients. The ART device is designed to utilize a hemo-protective flow approach aimed to rebalance saturation levels while patients are awake and breathing, potentially minimizing the patient’s need for mechanical ventilation.
The product is currently in a developmental stage and has not yet been tested or used in humans and has not been approved by the U.S. Food and Drug Administration (FDA).
For more information, please visit the company website:
We are now looking for a Medical Device V&V lead. How has experience in managing, planning, and executing the product V&V process, and want to join our inspiration!
Duties & Responsibilities:
Establishment company Verification and Validation infrastructure:
- Define V&V Strategy for product development throughout product lifecycle
- Define V&V testing methodologies and coverage.
- Plan and establish the company’s V&V test lab and test equipment’s
- Define and write the V&V testing working procedures.
- Work close with R&D, QA, regulation and take part in product development
Performing and managing the V&V tests:
- Write V&V Protocols and reports.
- Define and execute V&V tests for system and subsystem levels
- Managing and analyze tests data.
- define and manage the execution of Safety validation activities at 3rd parties for compliance with
applicable standards (EMC, Safety)
Experience and Knowledge Required:
- Extensive experience in V&V in a medical device startup
- Experience in planning and performing safety tests for medical products
- Working on a multi-disciplinary system (HW,SW, Mechanical)
- Excellent technical writing skills in English & Hebrew.
- Experience in participating of transferring product from research to production – advantage
- Biomedical /Biotechnology/ Mechanical Engineering – advantage
- Familiar with ISO 13485 and experience in QMS environment- advantage
Personal characteristics in need:
- Capable to combine managing and hands-on work.
- An initiator with self-drive
- Naturally curious
- Highly detail oriented
- High interpersonal skills