Vectorious Medical Technologies is a young and dynamic, fast-growing startup company located in Tel-Aviv. Our company has developed the world’s first in-heart microcomputer and is on a mission to transform heart failure treatment. As part of our clinical study, we have successfully implanted our sensory device in patients across Europe and Israel, while demonstrating a huge potential in helping millions of people living with heart failure to take control and manage their disease.
As the company is continuously growing, we are now seeking a V&V and investigation engineer. The candidate will be part of the team responsible for investigating the V-LAP systems (implantable and non-implantable products) and characterize its overall performance.
What will you do:
- Characterize tests, tested samples configuration and all other test parameters to in coordination with QA requirements.
- Define and develop test set-ups and equipment as needed.
- Investigate system’s issues and failures, performing root cause analysis to constantly improve the system.
- Participates in CAPA and MRB processes.
- Plan and execute V&V tests according to relevant standards.
- Write V&V protocols and reports for FDA submissions.
- Coordinate and manage 3RD-party testing and validation services
- Coordinate regulatory submissions (together with RA department)
- Works closely with R&D, QA, Regulatory and manufacturing teams
What do you need to bring with you?
- BSc in Electrical, Mechanical or Biomedical Engineering – must
- 1 years of engineering experience in a medical device company – advantage, with relevant experience in:
- V&V tests including protocol and report writing, conducting tests, and analyzing results
- Planning V&V activities including coordination with manufacturing departments and/or outsourcing mfg of samples and test equipment, coordinating with external labs, and outsourcing test services
- DFMEA and Risk Assessment processes
- CAPA, MRB and other QA-related Engineering
- Proven experience in technical writing (English) – must
- Familiarity with Medical-related ISO Standards (advantage):
- ISO 13485
- ISO 10555
- ISO 14708
- Strong problem-solving skills and outside-the-box thinking
- Meticulous, well-organized, and detail-oriented
- Highly dedicated and independent
- Team player