Job Description

Boston Scientific is seeking a highly motivated R&D software test engineer. The successful candidate will participate in the design and development of medical devices. Be a part of Boston Scientific’s R&D team to develop innovative products that sustain and improve the lives of patients around the world.  You will use your technical and collaboration skills alongside your passion for innovation and continuous improvement to drive growth through efficient and effective development of new products.

 

Job Responsibilities

  • Understand system requirements in detail, create and maintain test strategy that covers requirements, follows the internal standards, standard operating procedures and meets external/regulatory needs for medical devices.
  • Analyze and interpret the requirements correctly to come up with test designs that provide comprehensive coverage, and ensure requirement-to-test traceability
  • Ensure comprehensive coverage and coordinate with other groups to reduce testing overlap.
  • As appropriate, identify scenario-based tests that cover individual requirements as well as interactions between requirements / features / modules
  • Lead the development of actual test designs that provide comprehensive coverage and ensure requirement-design-test traceability.
  • Identify effective and efficient mode of test implementation and create high quality procedures to implement the test designs.
  • Participate in the formal execution of test procedures and follow the established processes prior to, during and after the test execution.
  • Participate and lead review activities to perform high quality reviews. (Example: test design, test procedures, test results, requirements etc.)
  • Maintain high quality documentation of the verification and testing plans, procedures/test-cases, and results
  • Ensure compliance of our software development process to the IEC 62304 standards
  • Lead a team of FW Test engineers to develop formal design verification and validation plans and perform or oversee testing in the lab.
  • Work with FW engineers to identify and minimize sources of technical and practical risk, and ensure the product meets medical device-related safety standards.

Desirable:

  • Good understanding of multiple technical fields. E.g, if you are an electronics engineer, it would be a bonus for you to have knowledge of mechanical engineering concepts (motors, pumps and fluid mechanics), or biomedical concepts (human anatomy, diseases, diagnostics, therapy)
  • Experience working in medical device domain
  • Experience working in a regulated industry (healthcare, automotive, aerospace)
  • Embedded system design / HW-SW interface knowledge.
  • Proficient in implementing Software in Loop, Hardware in Loop test methodologies.
  • Experience with requirements management / converting user needs into technical specifications.
  • Knowledge of data security and integrity, especially for a healthcare application.
  • Working knowledge of wired and wireless communication protocols

 

Minimum Qualifications

  • Bachelor’s degree (level 8) in Computer Science, Computer Engineering, or Electronics Engineering or equivalent.
  • 5+ years’ software development / test experience
  • 3+ years of experience in Medical Domain
  • Software / Firmware design / test experience for healthcare / medical domain
  • 5+ years’ experience in creating test frameworks and defining test strategy for a system as a whole which includes Software and Firmware.
  • Strong understanding of testing methodologies such as unit testing, manual and automated testing, testing of non-functional requirements, code coverage, etc., and ability to identify appropriate combination of these methodologies to ensure adequate test coverage
  • Knowledge of automated testing tools such as TBD
  • Experience with / ability to lead SW test engineers and mentor junior resources
  • Exposure to Product Verification and Validation activities
  • Strong verbal and written communication skills; ability to produce high-quality documentation
  • Self-starter and entrepreneurial in nature
  • Able to work in cross-functional and global teams, and participate in early morning or late-night calls

 

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