Subject Matter Expert

1 day ago

Bengaluru Karnataka, India AlgoShack Full time

**Job Summary**:
We are looking for a highly skilled **Subject Matter Expert (SME)** with deep knowledge of **medical devices, hospital workflow, and healthcare IT systems**. The SME will provide domain expertise, support product design and validation, ensure compliance with regulatory standards,

**Key Responsibilities**:

- 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**:

- Bachelor’s/Master’s 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?**

AlgoShack is a cutting-edge IT product based company focused on software test automation. At AlgoShack, you'll work on innovative projects with the latest technologies in a collaborative environment. We offer ample growth opportunities, a culture that values work-life balance, and competitive benefits.

**Location**:Bangalore

**Employment Type**: Full Time

**Experience**: 6+ Years

**Work Mode**: Work from Office

**Availability**: Immediate

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