Product/Solution Validation Engineer – Medical Software/Hardware

We are looking for a highly motivated Product / Solution Validation Engineer to lead the planning, execution, and documentation of validation activities for complete product or system solutions. This includes validating end-to-end functionality, system performance, user workflows, and regulatory compliance for integrated Medical hardware and software systems.

Key Responsibilities:

• • Plan, develop, and execute validation protocols for complete systems and integrated solutions (hardware/software).
    

  • Define validation strategies and acceptance criteria based on product requirements, risk analysis, and use cases.

  • Design and conduct system-level, user-level, and environmental validation tests.

  • Coordinate validation activities across engineering, manufacturing, and quality teams.

  • Document test results, file validation reports, and support regulatory submissions as needed.

  • Identify gaps in requirements or design and work with teams to address defects or deviations.

  • Ensure compliance with applicable standards such as ISO 13485, IEC 60601, IEC 62304, and FDA regulations.

  • Strong understanding on recent technologies AI, Computer vision and cloud computing.

Preferred Skills: 

• Prior experience with medical devices, diagnostics, or health technology products.

• Hands-on experience with test tools, lab equipment, and scripting for automated validation.

• Familiarity with risk management and usability engineering practices.

• Working knowledge of validation frameworks such as GAMP 5, V-Model, or Agile V&V.

• Excellent communication, organization, and problem-solving skills.

Required Skills:

• Strong understanding of product development lifecycles and validation processes.

• Experience with test planning, execution, documentation, and defect tracking.

• Familiarity with hardware/software co-validation and integrated systems testing.

Qualifications: 

• Bachelor’s or Master’s degree in Engineering (Biomedical, Electrical, Mechanical, or related field).

• 3-8+ years of experience in product validation, systems testing, or verification & validation (V&V), ideally in a regulated industry.

info.connect@visukhi.com