12 Jun
Sr. Validation Engineer - Medical Device - San Diego, CA
Vacancy expired!
This commercial stage Medical Technology organization is in need of strong Validation Engineers as they continue to improve their product line, which includes a Class III device. This company's products assist with brain surgeries and have numerous different components to their device, including fluidics, electromechanical, electrical systems, electronic readings, and many more. This R&D team is in need of highly skilled engineers who have experience validating complex Medical Devices with various methods of validation.
POSITION RESPONSIBILITIES:- Leads strategy for existing validation plan and updating validation protocols as needed.
- Responsible for problem-solving through troubleshooting, root cause investigations, and failure analysis of validation test failures.
- Participate in the development and results analysis of validation plans and test protocols to qualify and validate existing product design and process test methods.
- Write and coordinate efforts for the development and implementation of new and updated Quality System procedures and validation method procedures.
- Must be able to interface well with others.
- BS in Engineering (preferred) life sciences or other related
- Minimum of 5+ years' work experience in Validation Engineering
- Minimum of 3+ years' experience working in the Medical Device industry
- Experience with FDA requirements 21 CFR 820, knowledge of regulations such as GLP, GMP, ISO 13485 and other international regulatory requirements
- Strong & clear communication
- Technical writing and QMS system experience
- Health insurance
- Casual Dress code
- 401k match
Vacancy expired!