Job Description

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Review requirements, specifications, design documents, validation plans, and reports, user acceptance protocols, test protocols and reports, traceability matrices, and other documentation as required and provide feedback.

  • Provide expertise in establishing good software requirements, specifications, detailed design, verification and validation protocols, and planning documentation.

  • Support development teams on the validation of software tools.
  • Ensure the delivery of high-quality products (including requirements, design documentation, testing, and deployment procedures) while adhering to medical device industry standards and regulations.
  • Work with cross-functional teams to drive projects to completion.

    • QUALIFICATIONS/ KNOWLEDGE:


    Qualifications:

  • Bachelor’s degree required, preferably in computer science

    • Knowledge:

  • Minimum of 4 years of relevant medical devices software development experience.

  • Strong knowledge of software QA methodologies, tools, and processes.

  • Knowledge of up-to-date related standards and regulations.

  • Skilled in managing traceability matrices between all SDLC documents.

  • Top-level knowledge of test types and strategies: unit, integration, system, performance, stress, etc.

  • Experience with IEC 62304 – big advantage.

  • Knowledge of Software Configuration Management, CI, and CD technologies.

  • Experience working in an Agile/Scrum as well as a waterfall development process and the implications coming from the regulatory standards.

  • Excellent Documentation Skills and experience operating under Document Control.

  • Excellent communication skills in English.

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