Validation Engineer (Medical Device)

Title:

Valdiation Engineer (Medical Device)

Location:

Rochester NY Duration:

12

Months Overview:

This role supports validation activities for new products within a medical device manufacturing facility and requires the ability to work both independently and as part of a cross-functional team. Key Responsibilities Support validation work for new products, including laboratory testing utilizing VITROS analyzers. Prepare and handle clinical test specimens according to approved procedures, best practices, and safety requirements, including appropriate PPE. Perform pilot-scale formulations with biological materials, as needed. Operate and maintain laboratory equipment; complete all required documentation in real time (QC records, instrument logs, test records). Independently execute laboratory experiments and assist with troubleshooting instrument and test failures, as needed. Review and analyze data; document conclusions and test summaries in appropriate quality records within QuidelOrtho's quality system. Ensure organization, documentation, and tracking of long-term studies with multiple factors, products, and conditions. Maintain a working knowledge of cGMP requirements and adhere to all quality, regulatory, and safety guidelines. This role involves both laboratory and computer-based work.

Skills Required:

Bachelor's degree in a scientific field (e.g., Chemistry, Biology, or equivalent) required. Experience in an FDA-regulated industry and in validation for medical devices preferred. Familiarity with VITROS products and VITROS analyzers highly desired. Familiarity with biological formulations and processing techniques highly desired. Strong written and verbal communication skills with excellent attention to detail required. Strong organizational skills and ability to manage complex, long-term studies required. Proficiency in Excel required, with additional statistical analysis skills preferred.