Senior Design Quality Engineer

2 days ago

bangalore district, India Anumana Full time

About Anumana:

Anumana is a new AI-driven health technology company developing cutting-edge artificial intelligence models for ECG-based diagnostics. Our advanced algorithms leverage ECG, scans, and other inputs to enable early detection and intervention for heart-related diseases. By harnessing the power of AI, we empower healthcare providers to enhance patient care at every stage of the cardiac journey.

Responsibilities:

  • Participate in cross-functional teams supporting software design and development lifecycle.
  • Author, execute, perform, summarise, report out verification & validation test activities of components of a Software as a Medical Device (SaMD); which includes but not limited to: Test Plans, Test Procedures, User and Functional Requirements testing, Design Verification, Traceability Matrices, and Final Reports.
  • Ensure development projects meet defined development process requirements of FDA 21 CFR 820.30, EN/ISO 13485:2016 and IEC 62366-1.
  • Ensure software development is compliant with IEC 63204:2015 standard.
  • Facilitate the development of risk management activities for projects in compliance with ISO 14971:2019.
  • Ensure timely completion of all deliverables to support the design and development projects.
  • Share expertise with and support the developmental design change process for each project's specifications.
  • Actively participate in non-product software tool evaluation and validation process.
  • Ensure the quality of all design and development documents and records, so that they readily support regulatory submissions.
  • Support project-based activities through leading or supporting cross-functional initiatives.
  • Participates in continuous improvement activities by identifying and appropriately escalating process and product quality gaps.

Education and Qualification:

  • Bachelor’s Degree or equivalent in an Engineering or other scientific discipline or combination of education and relevant work experience.
  • 4+ experience years in SaMD or SiMD medical device development, verification and validation or relevant quality experience.
  • Experience in design verification and validation of medical devices; and understanding of and adherence to FDA, ISO and IEC design control procedures, regulations, and standards.

Skills:

  • Outstanding communication (oral and written) and interpersonal skills within all levels of the organization
  • Ability to manage projects efficiently and effectively.
  • Openness to collaborate in interest of project/organization.
  • Proactive and self-driven, possesses due sense of urgency
  • Shall possess systems mindset and good problem-solving abilities.

Benefits:

  • Work with some of the brilliant minds of the world solving exciting real-world problems.
  • Our benefits package includes the best of what leading organizations provide, such as stock options, paid time off, healthcare insurance, gym/broadband reimbursement.

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