Job Description :
Senior Test Engineer with Medical Device Experience
San Diego, CA
Long Term

Develop, implement and maintain test plans, protocols, test scripts and traceability matrix for design verification & validation.

Ensure the quality of the medical device software and hardware meets the design requirements
Ensure design requirements are testable
Develop, implement and maintain test plans, protocols, test scripts and traceability matrix for design verification & validation
Execute protocols/test scripts and document results
Generate and/or update summary reports
Participate in process improvements
Ensure compliance with FDA device regulatory requirements, including DHF and 510(k)
Follow internal Standard Operating Procedures, including documentation of testing procedures.
Using problem tracking software, report issues discovered during testing
Communicate with Hardware and Software Development, Marketing, Technical Services, and other project team members to ensure schedules and requirements are consistent with project expectations
Maintain design verification and validation documentation in accordance with established departmental and corporate procedures
Train individuals involved in verification and validation activities as needed
Participate in review and update of SOPs in the spirit of continuous improvement
Possess excellent verbal and written communication skills

Basic Qualifications: Typically requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience

Knowledge of testing medical products
Knowledge of FDA/cGMPs and global regulatory for Medical Devices
Good understanding of testing methodology and software development life cycle
Adequate discipline and professionalism to work diligently within published FDA device regulatory guidelines and rigorously follow internal Standard Operating Procedures, including documentation of the testing procedures
Ability to handle multiple tasks while ensuring timely and accurate completion
Proficient in developing test plans, protocols/test scripts, result reports
Must be skilled with standard Office applications