Design V&V Engineer

About Us

Sofwave (SOFW) is a fast-growing medical device company developing cutting-edge solutions in the field of aesthetic and skin rejuvenation using its proprietary Synchronous Ultrasound Parallel Beam technology. Founded in 2015 by a multidisciplinary team of engineers, physicists, and aesthetic industry experts, Sofwave is headquartered in Israel and serves a global market with advanced energy-based medical devices.

About the Role

As a Design V&V Engineer at Sofwave, you will play a key role in the design control process, working within a multi-disciplinary team that includes software, control, electrical, mechanical, and systems engineers. You will be responsible for planning, executing, and documenting verification and validation (V&V) activities across complex electro-medical systems. This is a hands-on position that combines technical rigor, system-level thinking, and cross-functional collaboration.

Key Responsibilities

• Develop and execute comprehensive V&V protocols and reports to verify product functionality, performance, and compliance with requirements.
• Perform hands-on testing of integrated hardware-software systems in lab and simulated environments.
• Document and manage test results, including data analysis, summary reporting, and defect tracking.
• Drive defect identification, root cause analysis, and resolution processes, including retesting and verification of fixes.
• Collaborate with R&D, Systems Engineering, and QA/RA to ensure product requirements are testable and risks are mitigated through verification.
• Participate in and support external testing activities (e.g., Safety, EMC, Environmental) at external laboratories.
• Contribute to design reviews and ensure compliance with Design Control, QMS procedures, and relevant standards.

Must-Have:

• B.Sc. in Electrical, Mechanical, or related engineering field.
• Minimum 3 years of experience in a V&V role at a medical device company.
• Proven experience with hardware/software system testing, writing, and executing test protocols.
• Strong understanding of ISO 13485, 21 CFR Part 820, and design control processes.
• Excellent documentation, analysis, and communication skills.

Nice to Have:

• Experience with energy-based aesthetic devices.
• Familiarity with regulatory testing standards (EMC, Safety, Environmental).
• Ability to work independently and collaborate effectively across teams.
  

Why Join Sofwave?

• Be part of a growing medical technology company making a global impact.
• Work on FDA-cleared, CE-marked innovations that reach clinics and patients worldwide.
• Collaborate with top-tier engineers, scientists, and industry experts.
• Enjoy a dynamic, purpose-driven work environment in the heart of medical device innovation.