Medical Device Validation Engineer | Hybrid & R&D

Defibtech, LLC.; Guilford, Northern (CT, KY); Hybrid; USD 65,000 - 95,000; Full time

Benefits offered by this job

Health benefits

401k plan matching

Paid time off

Job summary

Defibtech is seeking a Validation Engineer to join our Research & Development team in Guilford, Connecticut, onsite with hybrid flexibility. You will plan, design, develop, implement, and monitor validation strategies for next-generation medical devices.

Collaborate across functions to create test protocols and deliver FDA/CE compliant results. Excellent written and verbal communication, strong analytical skills, and the ability to manage multiple projects concurrently are essential for success

Qualifications

• Bachelor's degree in a science-related field or equivalent.
• 0-2 years of related experience.
• Experience in medical device design verification/validation preferred.

Responsibilities

• Plans validation strategies for medical device design functions (software, electrical, mechanical).
• Develops and executes validation protocols based on requirements and standards (ISO, FDA).
• Compiles and interprets results into reports for FDA and CE Mark approvals.
• Documents activities per procedures and regulatory requirements.
• Participates in Design Reviews and provides verification support (code reviews, module/system testing).
• Designs test equipment, fixtures, and testing software for device diagnosis.
• Supports compliance with FDA, Quality Management Systems Regulations, safety regulations and applicable statutes.
• Maintains strong communication and collaboration across teams.

Skills

Analytical skills

Communication

Problem solving

Cross-functional collaboration

Education

Bachelor's degree in science-related field

Tools

Test equipment

Job description

Defibtech is seeking a Validation Engineer to join our Research & Development team in Guilford, Connecticut, onsite with hybrid flexibility. You will plan, design, develop, implement, and monitor validation strategies for next-generation medical devices.

Collaborate across functions to create test protocols and deliver FDA/CE compliant results. Excellent written and verbal communication, strong analytical skills, and the ability to manage multiple projects concurrently are essential for success