Subject Matter Expert

Job Summary:

• Act as the

  domain expert

  for medical devices and hospital workflow management.
• Develop test strategies, test cases, and automation frameworks for PACS systems.
• Ensure compliance with healthcare IT standards, regulatory guidelines, and data security policies.
• Understand end-to-end hospital processes (OPD, IPD, Radiology, Pathology, ICU, OT, Pharmacy, Billing, etc.) and map them into solutions.
• Provide expert input in

  requirement gathering, product design, and solution architecture

  .
• Collaborate with R&D, engineering, and QA teams to ensure products meet

  clinical workflow and usability standards

  .
• Support

  validation, verification, and regulatory compliance

  (FDA, CE, ISO standards, etc.) for medical devices and hospital software.
• Conduct

  training sessions, workshops, and demos

  for internal teams, customers, and stakeholders.
• Lead and mentor teams in testing and validation processes.
• Research industry trends, new technologies, and evolving

  hospital/healthcare workflows

  to ensure solutions remain competitive and compliant.
• Act as a liaison between clinicians, biomedical engineers, and IT/automation teams to improve adoption and usability.

Required Skills and Qualifications:

• Bachelors/Masters in

  Biomedical Engineering, Healthcare Management, Clinical Engineering, or related field

  .
• 6+Yrs of experience in healthcare domain, medical devices, or hospital operations.
•  Experience with automation tools for healthcare IT testing.
• Strong knowledge of

  hospital workflows

  (patient journey, EMR/EHR, HL7, DICOM, HIS/LIS/RIS systems).
• Strong knowledge on PACS
• Strong expertise in Verification & Validation (V&V), system testing, and compliance.
• Familiarity with

  regulatory frameworks

  (FDA 21 CFR Part 11, HIPAA, ISO 13485, IEC 62304).
• Proven ability to lead and manage teams.
• Excellent analytical, problem-solving, and communication skills.

Why AlgoShack?