Bengaluru, Karnataka, India Req #264
Monday, July 15, 2024
About Mozarc Medical
At Mozarc Medical, our vision is to reimagine the future of holistic kidney health technology. Established in 2023 out of equal investments from DaVita, a leading provider of kidney care services, and Medtronic, one of the world's largest medical device companies, Mozarc Medical offers an exciting and unique start-up experience backed by the support of two long-time industry and market leaders.
Driven by our mission and values, we put our patients at the center of all we do. Our employees play a key role in developing technology solutions that enrich patients lives and create meaningful progress in the treatment of kidney disease. Find your purpose and passion at Mozarc Medical.
About Mozarc Medical
At Mozarc Medical, our vision is to reimagine the future of holistic kidney health technology. Established in 2023 out of equal investments from DaVita, a leading provider of kidney care services, and Medtronic, one of the world's largest medical device companies, Mozarc Medical offers an exciting and unique start-up experience backed by the support of two long-time industry and market leaders.
Driven by our mission and values, we put our patients at the center of all we do. Our employees play a key role in developing technology solutions that enrich patients lives and create meaningful progress in the treatment of kidney disease. Find your purpose and passion at Mozarc Medical.
Position Title: Senior Systems Engineer
A Day in the Life
- Working closely with Software architects and business leaders to define, design, and implement new connectivity platform features and services.
- Research, evaluate, and prototype new technologies to realize our connectivity vision and deliver the highest satisfaction to patients and clinicians.
- 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, design implementation.
- Discuss with system verification engineers to ensure that the system requirements are adequate and verfiable
- Define the use condition and use cases to develop the system features. Define the logics and provide inputs to the software team for implementing the use cases.
- Perform risk assessment for the product and develop risk mitigation strategies.
- Update of 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
Must Have
- Bacharel degree in Computer Science/ IT/ Electronics & Communication Engineering
- Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years experience managing requirements in the healthcare domain, with knowledge of medical device-related standards such as ISO 13485, US FDA's 21 CFR 820, IEC 60601, IEC 60068 and ISO 10993
Nice to Have
- 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
- 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 independatly lead project / coach team memebers
- 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 stake holders.
- Experience with IoT architecture and methodologies.
- Expertise with Microsoft Project, Excel, Word and PowerPoint
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.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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Other details
- Job Family System Engineer
- Job Function Engineering
- Pay Type Salary
- Required Education Bachelor's Degree
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