Med Device Validation Engineer – Hybrid/Onsite

Nihon Kohden America; United States; Hybrid; USD 70,000 - 95,000; Full time

Job summary

Defibtech is seeking a Validation Engineer to join the R&D team in Guilford, Connecticut. This onsite role offers hybrid flexibility, supporting the validation strategies for next-generation medical devices as part of a cross-functional team.

You will develop protocols from requirements, execute validation activities, and ensure proper documentation to aid FDA and CE Mark approvals while contributing to continuous improvement in quality systems.

Qualifications

• Bachelors degree and 0-2 years of related experience or equivalent
• Preferred: engineering discipline (electrical/biomedical/mechanical/computer science) with 2 years relevant experience
• Experience supporting manufacturing of electronic or electromechanical medical devices
• Knowledge of design verification and validation processes and practices

Responsibilities

• Plan, design, develop, implement and monitor validation strategies for medical devices.
• Develop and execute validation protocols based on system requirements and standards (ISO/FDACollates, FDA, CE).
• Document activities per best engineering practices and regulatory requirements.
• Participate in Design Reviews and provide verification support to development teams.
• Design test equipment, fixtures and software for device diagnosis and testing.

Skills

Analytical thinking

Technical writing

Team collaboration

Education

Bachelor's degree in engineering or related field

Tools

Test equipment

Job description

Defibtech is seeking a Validation Engineer to join the R&D team in Guilford, Connecticut. This onsite role offers hybrid flexibility, supporting the validation strategies for next-generation medical devices as part of a cross-functional team.

You will develop protocols from requirements, execute validation activities, and ensure proper documentation to aid FDA and CE Mark approvals while contributing to continuous improvement in quality systems.