This position requires knowledge that is acquired through experience, specialized education or training.
The role has clearly defined procedures and tasks as well as defined guidelines to aid in decision making.
The job requires a basic understanding of work routines and procedures in own discipline.
The technical procedures for this level are well defined.
The job works within well-defined procedures that may involve a variety of work routines.
This job typically requires a minimum of 2 or more years’ experience.
Able to work independently. Able to lift hardware (~ 50 pounds) and use material transfer equipment as needed.
Evaluates and refurbishes returned hardware.
Follows standard operating procedures (SOP's) and follows good documentation practices (GDP's) in refurbishing hardware.
Steps include assessment, testing, minor repair, cleaning and packaging.
Provides technical support to engineers and scientists on a variety of technical tasks.
Develops and recommends procedures and methods and prepares technical reports and documentation.
Performs technical evaluations of events to determine root cause; recommends corrective action.
Responsibilities are within the Technical Specialty/Skilled Trade Function as a generalist or in a combination of Disciplines.
Bachelor’s degree in a related field
Equivalent combination of education and experience is acceptable.
5+ years of applicable Regulatory/Clinical experience.
Thorough understanding of medical device regulations, guidance, labeling and promotional requirements; medical device quality systems; product development processes