Validation Engineer, Medical Devices (Hybrid)

Nihonkohden; Guilford (CT); Hybrid; USD 70,000 - 90,000; Full time

Job summary

Defibtech seeks a Validation Engineer to join our R&D team at Guilford, CT, with hybrid onsite flexibility. You will plan, design, and monitor validation strategies for next‑generation medical devices, developing test protocols from requirements and feedback to support patient outcomes.

Core responsibilities include validating software, electrical, and mechanical functions; executing protocols in line with ISO and FDA standards; documenting results for FDA/CE submissions; and collaborating

Qualifications

• Bachelor’s degree and 0–2 years of related experience or equivalent.
• Prefer degree in engineering (electrical, biomedical, mechanical, computer science) with 2+ years of relevant experience.
• Experience supporting manufacturing of electronic or electromechanical medical devices is highly preferred.
• Knowledge of design verification/validation and safety standards (IEC 60601, FDA, ISO).

Responsibilities

• Plan, design, develop, implement, and monitor validation strategies for medical devices.
• Develop test protocols from requirements and feedback to impact patient outcomes.
• Validate software, electrical, and mechanical functions and document results.
• Support FDA and CE submissions with cohesive reporting.
• Participate in design reviews and provide verification support to development teams.

Skills

Analytical skills

Technical writing

Communication

Project management

Education

Bachelor’s degree in engineering or science-related field

Tools

Test automation

Job description

Defibtech seeks a Validation Engineer to join our R&D team at Guilford, CT, with hybrid onsite flexibility. You will plan, design, and monitor validation strategies for next‑generation medical devices, developing test protocols from requirements and feedback to support patient outcomes.

Core responsibilities include validating software, electrical, and mechanical functions; executing protocols in line with ISO and FDA standards; documenting results for FDA/CE submissions; and collaborating