Vectorious Medical Technologies
- 27/11/2023
- תל אביב - יפו
Vectorious has developed the world’s first in-heart microcomputer and is on a mission to transform heart failure treatment. As part of our first in-human clinical study, we have successfully implanted our sensory device in patients across Europe, while demonstrating a huge potential in helping millions of people living with heart failure to take control and manage their disease.
Now, we are looking for a Verification and Investigation Engineer to join our team
Responsibilities:
Verifications:
- Plan and execute V&V tests according to relevant standards.
- Write V&V protocols and reports for FDA submissions.
- Define and develop test set-ups and equipment as needed.
- Characterize tests, tested samples configuration, test method validation and o all other parameters to in coordination with QA requirements.
Investigations:
- Become a key source of knowledge and POC in the company, for any technical challenges (mechanical, electronical and software).
- Investigate system’s issues and failures, performing root cause analysis to constantly improve the system.
- Participates in quality processes such as CAPA, complaints, etc.
- Coordinate and manage 3RD-party testing services.
- Coordinate regulatory submissions (together with RA department)
- Works closely with R&D, QA, Regulatory, engineering and manufacturing teams
Qualification:
- BSc in Electrical, Mechanical or Biomedical Engineering – must
- At least 3 years of engineering experience in a medical device company, with relevant experience in:
- V&V and benchmark tests including protocol and report writing, conducting tests, and analyzing results.
- Planning V&V activities including manufacturing, scheduling, and subcontractors.
- DFMEA and Risk Assessment processes
- CAPA, MRB and other QA-related Engineering
- Proven experience in technical writing (English) - must
- Familiarity with Medical-related Standards: ISO 13485, 10555, 14708 IEC 60601-1
- Experience with planning and execution of test according to ASTM standards
- Meticulous, well-organized, and detail-oriented
- Highly dedicated and independent
- Strong problem-solving skills and outside-the-box thinking.
- Team player
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