Medical Device Validation Engineer (Hybrid)

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

Benefits offered by this job

Health benefits

Disability insurance

401(k) with company match

Job summary

Defibtech is seeking a Validation Engineer to join our Research & Development team in Guilford, CT, with hybrid flexibility. The role focuses on planning, designing, and executing validation strategies for next-generation medical devices, influencing patient outcomes through cross-functional collaboration.

The ideal candidate holds aBachelor's degree in an engineering or science field with 0–2 years of related experience; medical device validation knowledge and experience with ISO and FDA

Qualifications

• Bachelor's degree in engineering or related science field; 0–2 years of experience required.
• Preferred: engineering discipline (electrical, biomedical, mechanical, or computer science) with 2+ years of relevant experience.
• Experience supporting manufacturing of electronic or electromechanical medical devices is highly preferred.

Responsibilities

• Plans, designs, develops, implements, and monitors validation strategies for medical devices.
• Develops and executes validation protocols compliant with system requirements and standards (ISO/FDA).
• Compiles and interprets protocol results for FDA/CE submissions.
• Documents activities per engineering practices and regulatory requirements.
• Supports design reviews and verification activities across development teams.

Skills

Analytical thinking

Problem solving

Written communication

Oral communication

Organizational skills

Teamwork

Education

Bachelor's degree in engineering or sciences

Job description

Defibtech is seeking a Validation Engineer to join our Research & Development team in Guilford, CT, with hybrid flexibility. The role focuses on planning, designing, and executing validation strategies for next-generation medical devices, influencing patient outcomes through cross-functional collaboration.

The ideal candidate holds aBachelor's degree in an engineering or science field with 0–2 years of related experience; medical device validation knowledge and experience with ISO and FDA