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