Job Description

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