Hybrid Medical Device Validation Engineer

Nihon Kohden America; Guilford (CT); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health benefits

Disability insurance

401k with company match

Job summary

Defibtech is seeking a Validation Engineer to join our R&D team in Guilford, CT. The role is onsite with hybrid flexibility and will drive validation strategies for next-generation medical devices.

You will design and execute validation protocols, analyze results, and prepare reports for FDA and CE approvals while supporting design reviews and testing activities. Strong communication and detail-oriented skills are essential.

Qualifications

• Strong analytical and problem-solving abilities are essential for validating medical devices.
• Excellent written and verbal communication skills required for documentation and cross-functional work.
• Experience with design verification/validation processes and safety standards is preferred.

Responsibilities

• Plan, design, develop, implement, and monitor validation strategies for medical device releases.
• Develop validation protocols and tests per system requirements, ISO and FDA standards.
• Collate and report validation results for FDA/CE Mark approvals.
• Document activities following procedures and regulatory requirements.
• Support design reviews and verification activities (coding reviews, testing, test automation).
• Design test equipment, fixtures, and testing software for device diagnosis.
• Promote Defibtech values and continuous improvement, ensuring regulatory compliance.

Skills

Analytical thinking

Problem-solving

Written communication

Oral communication

Attention to detail

Teamwork

Independent work

Education

Bachelor's degree in Engineering or related field

Tools

Test equipment

Measurement equipment

Job description

Defibtech is seeking a Validation Engineer to join our R&D team in Guilford, CT. The role is onsite with hybrid flexibility and will drive validation strategies for next-generation medical devices.

You will design and execute validation protocols, analyze results, and prepare reports for FDA and CE approvals while supporting design reviews and testing activities. Strong communication and detail-oriented skills are essential.