Job Description

Responsibilities:
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.

• 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 thedocumentation.
• 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
• 5+ 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 (ISO13485, 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.

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