Senior MDR/SOTA Engineer
Utilize relevant GSPR (General Safety Performance Requirement) standards to gap current device documentation to create remediation plan.
Establish worst case code criteria with support from multifunctional team in order to determine test strategy.
Gather info from multifunctional teams, device information and prepare comprehensive form (Device profile forms).
Complete and revise Bill of Material forms to gather information on material, suppliers, patient contact level, surface area etc.
Work with manufacturing sites to revise process flow diagrams & maps in conjunction with the validation team.
Establish patient contact areas, maximum number of devices & contact duration in conjunction with Medical/Clinical affairs.
Complete Technical Change Request forms for biocompatibility, stability, sterilization
Track TUVR MOC result testing.
Confirm TUVR MOC findings to hand off to engineering for remediation.
Remediating any deficiencies identified as part of tech file submission audit.
Support miscellaneous regular day to day MDR/SOTA activities to support the greater team as needed.
Track progress, call meetings when necessary handle misc. documentation & database tasks.
Must Have: Minimum Requirements
Bachelors degree in Mechanical Engineering or Biomedical is required
Minimum of 7 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
Knowledge of U.S. FDA and EU MDD & MDR medical device regulations and guidance is required
Demonstrated experience with planning, oversight, and execution of multiple projects is required; project management training & certification is a plus
Familiarity with international regulations and guidance (such as China, Brazil, Japan, etc.) a plus
Knowledge of Surgical Instruments
Excellent written and oral communication skills
Candidate must be able to have a flexible work schedule in order to overlap at least 4 hours/day with EST working hours.
Apply for the Job