Systems Engineer

Full Time
Posted 1 day ago

one of the largest radiology companies in the world is hiring

Reporting toHead of Product DevelopmentRole typeFull time
DepartmentProduct DevelopmentLocationChennai
Role overview
The primary purpose of your role is to help build various healthcare applications, manage and monitor all installed systems and infrastructure. In doing so, you’ll be able to ensure high levels of systems and infrastructure reliability. This role will suit someone who is passionate about working on break-through software products that positively impact patients’ lives at scale.  You will be working closely with our Lead Systems Engineer and other Engineering team members in driving requirements development, risk management & interface architecture design for our Company enabled radiology product portfolio.  
Key responsibilities
-Requirements engineering, safety risk management (per ISO 14971), system and interface design in a
Software as a Medical Device (SaMD) context.
-Work closely with Software teams to build/review System/subsystem architecture and design.
-Collaborate with Project Management to help plan and manage risk.
-Support requirements development, user stories and backlog management in collaboration with
Product Management for features, enhancements or fixes, ensuring that UX, Regulatory, Clinical and
Marketing needs are met.
-Collaborate with QA on developing the procedures and work instructions for our QMS.
-Work closely with the Software development team to evaluate technical design alternatives to achieve
desired functionality.
-Ensure non-functional requirements including UX, scalability, performance, supportability and
reliability are identified and followed.
-Develop and maintain a deep understanding of Company processes and workflows, as well as an
expertise in the functions and data of Company systems and applicable regulatory guidance and
-Review verification and validation testing strategies.
-Development and conduct of test protocols.
-Keep in close step with changes to standards and regulations.
-Comply with all company policies, procedures and guidelines including those relating to information
Minimum Qualifications
– Bachelors/Masters degree in Bio-medical/Computer Science/Electrical & Electronics/ Information
Systems or equivalent
– Min. 10 years’ experience in a professional Engineering role or equivalent
-Strong background in Software development or Software Verification of complex systems.
-Sound understanding of the Product development process and Software development life cycle.
-Experience in engineering products in a regulated space (Healthcare, Avionics, Automobiles, etc..),
preferably Healthcare.  
Preferred Qualifications
– Experience with SaMDs (Software as a Medical Device) or SiMD (Software in a Medical device) with
good knowledge of IEC 62304, ISO 13485, IEC 14971, 21 CFR Part 820.
– Experience in working on submissions for regulatory approvals e.g. FDA, TGA, MDD/MDR.
– Experience with Cyber-security guidance and best practices.
– Experience with scrum agile development methodologies.  

Work Location : Chennai

CTC : Upto 70.0 LPA

Interested candidates please call us on : 9845264304/9035007003/9035302302 or email resume to :

Job Features

Job CategoryMedical Devices

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