Senior System Verification Engineer

4 weeks ago


Pune, Maharashtra, India Boston Scientific Full time

About the Role

We are seeking a highly skilled Senior System Verification Engineer to join our team at Boston Scientific. As a key member of our development team, you will be responsible for developing equipment and tooling used in the development and production of medical devices.

Key Responsibilities

  • Develop clear specifications, feasibility plans, and reports for system integration tests.
  • Ensure adequate translation of system requirements to module requirements.
  • Participate in requirements analysis and designing of test strategies and test procedures/scripts to evaluate the behavior of the system/software/firmware as compared to the specified requirements.
  • Plan and execute system integration and system/software verification activities.
  • Complete project deliverables and monitor project schedule and scope changes to assure team can meet delivery requirements.
  • Prepare standard reports/documentation to communicate status and results.
  • Create, review, and approve required FDA/QSR equipment documents including specifications and qualifications.
  • Support system risk management activities, Use/Design FMEA's, risk/hazard analysis.

Requirements

  • B.E./B.Tech in ECI, Biomedical preferred.
  • 8-11 years of experience to be considered.

Preferred Qualifications

  • Manual Tester, Engineer should have automation with Python knowledge.
  • Testing experience in medical device (Implant Experience) is required.
  • Must have ISO Standard 13485.
  • Manual Tester

Good to Have

  • 62304

About Boston Scientific

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.



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