AI-Powered Medical Devices Quality Expert

1 week ago

Bengaluru, Karnataka, India beBeeQuality Full time ₹ 1,80,00,000 - ₹ 2,50,00,000

About us: We are 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.

Our mission is to empower healthcare providers to enhance patient care at every stage of the cardiac journey.

We're seeking a Senior Design Quality Engineer who will participate in cross-functional teams supporting software design and development lifecycle. The ideal candidate will have experience in design verification and validation of medical devices and understanding of FDA, ISO and IEC design control procedures, regulations and standards.

  • 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.
  • Facilitate the development of risk management activities for projects in compliance with ISO 14971:2019.
  • Actively participate in non-product software tool evaluation and validation process.
Requirements
  • Bachelor's Degree or equivalent in an Engineering or other scientific discipline or combination of education and relevant work experience.
  • 4+ years of experience in SaMD or SiMD medical device development, verification and validation or relevant quality experience.
Skills
  • Outstanding communication and interpersonal skills within all levels of the organization.
  • Ability to manage projects efficiently and effectively.
What we offer
  • The opportunity to work with some of the brilliant minds of the world solving exciting real-world problems.
  • A competitive benefits package including stock options, paid time off, healthcare insurance and gym/broadband reimbursement.

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