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
Qualifications:
• 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
Desired/Preferred Qualifications:
• 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.
Top Skills
What We Do
Zealogics LLC provides a broad range of IT consulting, systems implementation and application outsourcing services through an optimized global delivery model. Zealogics builds deep knowledge of traditional product engineering across mechanical, electronics and software platforms, to enable clients to navigate their digital transformation.
Zealogics values engineering techniques, automation frameworks, and reference models which are refined through engagements with Fortune 500 enterprises and OEMs. We combine customer-centric product strategies through a collaborative approach for execution. We help to harmonize processes, identify bottlenecks, and eliminate non-value tasks to deliver world-class products.
With impeccable focus on client needs we connect specialized resources for the right positions, both for full time and contractual placements. Our long-term relationships with employees and clients have been built in an environment of integrity and commitment, with a shared goal of mutual success. Zealogics hires experienced people to solve a wide array of IT and Engineering challenges that our clients face. Our guarantee - Zealogics provides the best value services in town.
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