IoT Architect

Position : IoT - LSH Architect

Location : Remote is fine

Responsibilities:

• Technical Sales support
• Customer site visits and requirement gathering
• Solution & Architecture
• Consulting & Pilot projects
• Customer engagement and New business opportunity support

Qualifications:

A Bachelor / Master degree in a Computer Science / Biomedical / Mechanical / Design Engineering

with a solid foundation in complex and distributed software system design, development,

implementation and quality assurance. Experience in Machine Language and Artificial Intelligence is

a plus. Experience with Big Data software technologies is a plus.

Essential Skills:

12+ years of direct experience in developing solutions and building services for

Healthcare/Pharma specific Clinical Solutions, in particular, in the areas of HIE, EHR/EMR, Healthcare

Informatics, Telehealth, Mobile Health, EDC, safety systems, Healthcare Security, Pharma

Informatics and corresponding Business Model development.

10+ years of experience in Class I, Class II Medical Devices software engineering, Software as a

Medical device, including regulatory lifecycle

10+ years of direct experience in Pharma clinical development process with regards to protocol

development, Clinical workflow design, project planning, randomization, blinding/un-blinding,

clinical trial setup and data collection, clinical data management, safety monitoring & reporting and

submission to global Health Authorities.

In-depth understanding and working knowledge of various top tier Pharma and Healthcare systems

particularly, Medidata Rave, OC/RDC, Argus, various CTMS systems including Veeva Vault, ERM

systems such as Epic, CERNER, Allscripts etc.

Hands on experience on data integration between Pharma systems including various CTMS, eTMF &

CDMS, integration with lab systems & integration with various Healthcare systems.

Extensive hands-on experience as a technical lead as part of a complex software enterprise product

development working on architecture, design and implementation.

Experience delivering software projects utilizing FDA design controls is required

Experience developing software as a service (SaaS) on a public cloud

Domain expert in software engineering quality management system (QMS)

Define and Deliver standard IoT Platform (Azure, AWS, GCP, PTC, etc.)

Scaled Agile Framework (SAFe) experience is preferred

Experience in data extraction, ingestion, validation from medical devices into cloud environments

(AWS, GCP, MS Azure, etc.)

Hands-on RESTful & Web API development

Working knowledge of HL7, FHIR, JSON, XML, CSV data formats

Lead risk management process including the identification and mitigation of failure models (FMEAs)

Work with medical device software engineers to identify the engineering requirements, testing

needs, and traceability artefacts required for the design history file (DHF)

Partner across multiple operating segments including Application Development and Cybersecurity to

realize the IoT vision

Partner with Client Med Devices R&D Product Development organization to understand their IoT

needs, help prioritize investments, develop use cases, generate processes, and develop overall

solution requirements including application definition, integration, security, and system

configurations

Build and roll-out design processes to SCRUM teams