System Architect
System Architect
design, develop and maintain CT/AMI (Computed Tomography / Advanced Molecular Imaging) products and solutions. This opening is for India Product Engineering group of CT/AMI at HIC Pune.
Your role:
- Carrying out all System Engineering activities of assigned product(s)/product line(s) as per the global system engineering process
- Analyze product(s) issues from the field (post market) and take complete ownership in providing relevant solution(s)
- Provide solutions for Hardware/ Software obsolescence management
- Be interface to and take complete ownership in managing the hardware/software deliverable from internal and external supplier
- Improving customer satisfaction through providing excellent solutions to existing customers
- Participate and perform risk analysis according to applicable medical device standards
- Deep understanding of US and international regulatory requirements and standards for a heavily regulated product (ISO 14971, IEC60601-1, IEC62336 EMC standard, etc.) preferred
You're the right fit if:
- Master/bachelor’s in engineering – Computer Science/Information Technology/Electronics/ Controls Engineering
- 10+ of experience in designing & developing medical devices / products with Minimum 5 years of experience in end-to-end design and development for subsystems (Control systems preferred)
- Experienced in design / development of complex technological products / systems / subsystems in functional area.
- Experienced in control system/Imaging software design and development preferred
- Experience is CT / Nuclear Medicine product development is preferred
- Experience in hardware/ software obsolescence management is preferred
- Knowledge of IEC standards, risk management, verification and validation of medical devices
- Knowhow of design control processes for medical device design
- Fast learner and interest to learn new technologies/business/systems
- System thinking mindset and domain expertise in the related area
- Excellent communication skills, Team player, Leadership skills and drive for results
- Mindset to simplify and reach to solutions with speed
- Knowledge of IEC 60601, IEC62304 standards, risk management, verification and validation of medical devices
- Develop a plan for the orderly phase-out of the software, ensuring users transition smoothly to new versions or alternatives.
- Prior experience with Installed base/LCM group preferred
This role is an office-based role.
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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