IoT - LSH Architect

Role : IoT - LSH Architect
Location : Remote is fine
Duration: Contract

Job Description:-

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's 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