12 Jun
Sr. Validation Engineer - Medical Device - San Diego, CA
California, San diego , 92103 San diego USA

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.

To succeed in this role, you should have the following skills and experience

:
  • 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

Benefits:
  • Health insurance
  • Casual Dress code
  • 401k match
Make the best career decision ever. Send us your resume.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Vacancy expired!


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