Senior Systems Engineer - 23000F5K

Job Description:

A Day in the Life

One of the key deliverables of MIDC is an electromechanical product that will be used in a clinical setting.  We are looking for a Lead systems engineer who will work on capturing system requirements, concept design, system modelling, risk analaysis, system.  Given the entrepreneurial nature of MIDC, this person will have to perform hands-on work in the mechanical/systems lab. 

• 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

• 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 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

Desired / Preffered Qualifications

• 3+ 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
• 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

About Client
Together, we can change healthcare worldwide. At Client, we push the limits of  what technology, therapies and services can do to help alleviate pain, restore health and extend life.

We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team.

Let’s work together to address universal healthcare needs and improve patients’ lives.Help us shape the

future.

Whatever your specialty or ambitions, you can make a difference at Client - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.