Senior Software Engineer- Immediate role

Bangalore, Karnataka, India
Full Time
Mid Level
Position Description
This position will provide software system engineering support in developing a graphical user interface for a medical product for performing kidney dialysis through technical architecture, system level definition, and verification activities.

Position Responsibilities:
  • 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 documentation.
  • 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 preferred
  • 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
Basic Qualifications:
  • 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
Desired/Preferred Qualifications:
  • 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.)
  • Entrepreneurial spirit’

 
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