Validation Engineer (Medical Device)

Rochester, NH - USA

Monthly Salary: Not Disclosed

Posted on: 18 hours ago

Vacancies: 1 Vacancy

Job Summary

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 QuidelOrthos 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:
Bachelors 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.

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 R...