Medical Device Validation Engineer - Hybrid

Defibtech, LLC; Guilford (CT); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Health benefits

Disability insurance

401(k) plan

Paid time off

Job summary

Defibtech, LLC in Guilford, CT seeks a Validation Engineer to join the R&D team onsite with hybrid flexibility. You will design, implement, and monitor validation strategies for next-generation medical devices, developing test protocols and reporting to support FDA and CE Mark approvals.

The role requires a bachelor’s degree in a science/engineering field and 0–2 years (2+ preferred) of related experience, with strong analytical, writing, and communication skills.

Qualifications

• Bachelor's degree in a science-related field and 0-2 years related experience.
• Experience in medical device manufacturing preferred.
• Knowledge of design verification and validation processes (IEC 60601-1, FDA, ISO) preferred.

Responsibilities

• Plans, designs, develops, and implements validation strategies for medical devices.
• Develops test protocols based on requirements and feedback to impact patient outcomes.
• Composes cohesive validation reports for FDA/CE Mark approvals.
• Documents activities per engineering practices and regulatory requirements.
• Participates in design reviews and provides verification support to development teams.

Skills

Analytical thinking

Problem solving

Technical writing

Communication

Organizational skills

Team collaboration

Independent work

Education

Bachelor's degree in Engineering/Science

Tools

Test equipment

Job description

Defibtech, LLC in Guilford, CT seeks a Validation Engineer to join the R&D team onsite with hybrid flexibility. You will design, implement, and monitor validation strategies for next-generation medical devices, developing test protocols and reporting to support FDA and CE Mark approvals.

The role requires a bachelor’s degree in a science/engineering field and 0–2 years (2+ preferred) of related experience, with strong analytical, writing, and communication skills.