Zealogics IT Solutions
9th Floor, A1, Trans Asia Cyber Park Infopark Phase-II, Cochin
Software Systems Engineer
Define/ Author high quality GUI (Graphical User Interface) software requirements, use cases and workflows for a critical medical product software subsystem.
Define/ Author high quality embedded software / firmware requirements, use cases and workflows for a critical medical product software subsystem.
Ability to work with cross functional teams to understand the high-level systems requirement (product system
requirements, stake holder needs) and breakdown into software requirements.
Manage the multiple software systems documents starting from authoring, reviewing, work and release of the
Work with screen design teams (Human Factors) to develop the user interface workflows, error scenarios etc. to ensure the traceability and coverage of the requirements, use cases / conditions.
Collaborate with software development and test teams in creating technical feasible requirements, workflows and use cases.
Create and manage the UI (User interface) specification document in collaboration with screen design (human factors) team.
Work closely with software development and test teams to develop the medical product software.
Define/ Author Security and compliance requirements for the system in collaboration with security and product systems teams.
Thorough understanding of creating test protocols for verifying software requirements. Plan and execute system level validation.
Collaborate with quality and regulatory colleagues to ensure compliance
Participate/Lead risk assessments and develop mitigation plans (FMEA) to ensure safe operation of the product
Participate in strategic discussions and own the technology development for the future generation of the product
B.E. from reputed university in Computer Science/Engineering or Electronics Engineering
7+ years combined experience in software development / software systems engineering, from concept to launch
5+ years of experience in high quality software requirements definition / authoring, reviewing.
Experience in understanding software user interface screen workflows, use cases and conditions, error scenario handling.
Strong system thinking skills and experience. Creating easy to use software system solutions
Ability to understand the product needs, customer perspective and experience in translating high level requirements to excellent high quality software requirements.
Very good documentation skills with good documentation practices.
Strong written and verbal communication skills, with attention to detail and thoroughness
Able to work in direct, cross-functional and cross-cultural teams, with strong influencing skills
Able to participate in late evening and/or early morning calls
Strong organization and time management skills; ability to manage multiple priorities
Self-starter, strong work ethic and initiative in accomplishing objectives, and delivering in ambiguous environments
Medical Device development experience, strong knowledge of medical device quality and regulatory standards (ISO 13485, ISO 14791, IEC 60601, IEC 62304, etc.), CFR 820.30 for FDA, DICOM, HL7 Communication standards.
Working knowledge in Dialysis machines
Working knowledge of information security, especially as applicable to healthcare sector
Working knowledge of hardware and electromechanical engineering concepts (microprocessors/microcontrollers,
wired/wireless communications, motors, sensors, valves, fluid circuits, etc.)