Position: Software Testing

Experience: 0-2 Years

Job Location: Pune

• Bachelor’s degree in Computer Science, Software Engineering or equivalent
• The position requires performing compliance to software quality for medical software by ensuring adherence to software development standards
• The work includes close partnership with the software development teams, test teams and the systems engineering teams to manage all aspects of quality and documentation for medical device software.
• Fluency in English Communication is must.
• Certification in any software courses would be a plus.

Salary: As Per Company Norm

Job Types: Full-time, Permanent, Fresher, Experience

Engineers are the key to success in our organization. We value our engineers and their skills
in furthering the cause of helping lives. This opportunity is in the IZiel Healthcare division. IZiel
group is in the business of providing engineering and regulatory services, engineering design
and analysis and resource placement services. We work with global medical device
manufacturers, automotive, engineering and oil and gas clients. Thorough leadership, robust
work planning methodology and exceptional customer service are the key enablers of our
success.

The position requires performing compliance to software quality for medical software by
ensuring adherence to software development standards. The work includes close partnership
with the software development teams, test teams and the systems engineering teams to
manage all aspects of quality and documentation for medical device software.

• Actively participate in product development lifecycle to ensure that the design control
processes are followed and ensure compliance to IEC 62304 and IEC 82304 standards
for software
• Perform gap analysis of deliverables against the SW lifecycle standards
• Drive SOP updates or creation of new processes based on upcoming standards or
process improvements
• Drive Risk Management activities to create risk management files in alignment with
ISO 13485 standards
• Contribute to test method creation, review and approval of test protocols to support
VnV activities
• Lead adherence to processes for technical design reviews, code reviews, traceability
analysis Change Control Board Reviews and Defect Management Board Reviews.
• Be able to perform software quality audits and prepare teams for audits

DESIRED QUALIFICATIONS:

• Bachelor’s degree in Computer Science, Engineering or equivalent.
• 0 to 2 years of experience in various phases of SDLC and quality requirements for
medical device software
• Hands on experience in performing risk analysis, requirements traceability and usage
of tools such as design FMEA or user FMEA’s
• Strong verbal and written communication skills, ability to produce high quality
documentation
• Able to work in cross-functional and cross-cultural global teams with a sharp focus on
quality and customer experience

PREFERRED QUALIFICATIONS:

• Full product lifecycle experience
• Experience in Security Assessments, Security Testing and Usability Testing for
Medical Device Software