Medical Device Validation Engineer I

BEPC Inc. - Business Excellence Professional Consulting; Santa Clara (CA); On-site; USD 82,656 - 85,411; Full time

Job summary

A specialized engineering consulting firm in Santa Clara is seeking a Validation Engineer I. The role involves ensuring compliance and quality control within the medical industry, with responsibilities that include developing qualification protocols and managing validation projects. Ideal candidates will have a Bachelor's degree in Engineering or Science, and at least one year of relevant experience in a regulated environment. Strong analytical skills and collaboration capabilities are essential for success in this position.

Qualifications

• 1 year of validation experience in medical device, pharmaceutical or similar regulated industry.
• Knowledge of ISO 13485, FDA 21 CFR Part 820, Part 11, GMP, and GAMP standards.

Responsibilities

• Develop equipment and fixture matrices for medical device regulations.
• Execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols.
• Manage multiple validation projects simultaneously.

Skills

Quality Control

Risk Management

Technical Documentation

Analytical Skills

Collaboration

Education

Bachelor’s degree in Engineering, Science, or related technical field

Job description

A specialized engineering consulting firm in Santa Clara is seeking a Validation Engineer I. The role involves ensuring compliance and quality control within the medical industry, with responsibilities that include developing qualification protocols and managing validation projects. Ideal candidates will have a Bachelor's degree in Engineering or Science, and at least one year of relevant experience in a regulated environment. Strong analytical skills and collaboration capabilities are essential for success in this position.