Sr Systems Engineer

Position Title 

Senior Systems Engineer

A Day in the Life

Responsibilities:

Position Responsibilities:

• Working closely with Software architects and business leaders to define, design, and implement new connectivity platform features and services.
• Knowledge of regulatory (FDA, EU) requirements and frameworks applicable to medical products.
• Awareness of emerging and existing legislation with security implications (e.g., DiGA, GDPR, CCPA).
• Work with customer-facing team members (human factors and voice-of-customer specialists) to understand user needs and convert them into high-level product specifications. Develop detailed technical requirements, and ensure accurate flow-down to sub-system requirements, and design implementation.
• Discuss with system verification engineers to ensure that the system requirements are adequate and verifiable
• Define the use condition and use cases to develop the system features. Define the logic and provide inputs to the software team for implementing the use cases.
• Perform risk assessment for the product and develop risk mitigation strategies.
• Update the requirements based on the risk control measures recommended in the risk management file
• Work with quality/reliability engineering to identify and minimize sources of technical and practical risk, and ensure the product meets medical device-related safety standards.
• Work with clinical and regulatory groups to ensure the product is approved for commercial use
• Review the design inputs and outputs to ensure quality
• Define GUI (Guided User Interface) software use case development for an electromechanical system to be used for performing kidney dialysis.
• Support GUI software development on the Android operating system

Define Security and compliance requirements for the system and ensure the conversion into solutions

Essential Qualifications:

• 6-8 years of experience in medical or aerospace domain with B.E. or B.Tech. in Computer Science/ IT/ Electronics & Communication Engineering from a reputed university. 
• Hands-on experience in Requirements and risk management
• Understanding of electronics concepts (microcontrollers, power supplies, programmable logic)
• Experience in requirement management, risk management(FMEA, PHA) for system, mechanical/electrical systems
• Knowledge of medical device quality and regulatory standards (ISO 13485, ISO 14791, IEC 60601, IEC 62304, etc.)
• Ability to independently lead project/coach team members
• Good verbal/written communication skills. Ability to produce good quality documentation.
• Ability to work in a global environment and interact with various internal and external stakeholders.
• Experience with IoT architecture and methodologies.
• Expertise with Microsoft Projects, Excel, Word, and PowerPoint

Nice-to-have Qualifications:

• B.E, B.Tech, M.E, M.Tech degree in CS, ECE, IS.
• Basic understanding of designing, building, and maintaining scalable and reliable platforms using cloud technologies (e.g., AWS, Azure, GCP).
• Understanding of biomedical concepts (human anatomy, disease, diagnostics, therapies)
• Working knowledge of dialysis therapy
• Basic understanding of biomedical concepts (human anatomy, disease, diagnostics, therapies)
• Experience in MBSE

Why Work with Us? 

Working here is highly rewarding – we have the privilege of helping kidney patients experience greater freedom, improved outcomes and a renewed passion for life. 

It’s essential our team members feel valued, supported and empowered too. That’s why we provide a comprehensive total rewards package and opportunities to grow, develop and give back to the communities where we live and work – helping you reach your potential and enjoy a career full of life-changing possibilities.