Job Description

Purpose Statement:

To ensure the quality of Boston Scientific Corporation’s software applications and equipment by validating/qualifying to specifications. Provide comprehensive documentation (specifications and validation/qualifications) per the division's policy to meet FDA regulations.

Job Respondsibilities:

  • Participate in project teams to develop comprehensive specifications (hardware and/or software) for equipment with minimal functionality such as fixtures, PLC's, and simple Visual Basic applications.
  • Provide project estimates with assistance from senior/principle engineers.
  • Submit specification, protocol and report for approvals and documentation control via a Change Request.
  • Develop comprehensive software validations and/or equipment installation qualification protocols per the specification.
  • Execute software validation and/or qualification protocols & record results.
  • Document, communicate and fo...

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