Verification and Investigation Engineer

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:

1. V&V and benchmark tests including protocol and report writing, conducting tests, and analyzing results.
2. Planning V&V activities including manufacturing, scheduling, and subcontractors.
3. DFMEA and Risk Assessment processes
4. 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