Job Description:

Support the Software Test and Tool Development activities for medical equipment development project. The expert needs to plan, develop & execute software testing & evaluate the verification status of the product. This role also requires working with a globally distributed team working on the product development, verification & release.

Key Responsibilities:

• Actively working with a team of Product Software verification Engineers, System Engineers, Hardware and Firmware Engineers.

• Ensures the quality of software systems, validate product software requirements, security requirements and compliances.

• Creation and execution of Design Verification Plan, Protocols and Reports to perform SW testing of products and report any issues discovered.

• Interaction with various stakeholders including SW development, verification, QA/ RA teams

• Perform review of design, development, and testing of software used in medical device product lines.

• Actively working to support Automated Test Equipment validation activities.

• Actively working on Software related CAPA.

Qualifications:

• (3-8) years of understanding and experience in the testing & tool development of software for medical capital equipment development activities. Working experience in medical devices (at least 2 years) is mandatory.

• We are looking for Proven experience in manual testing i.e. understanding of product requirement, risk assessment, creation of protocol, execution, report creation and providing product verification status is required.

• Experience of working with measuring devices e.g. Oscilloscope, Multimeter etc. in a Lab set-up.

• Proficient in System testing with HW background is desired.

• Proficient in creation of DFH for FDA 510K/ ISO 13485 Submission.

• Experience with tools like Jira, Windchill, Cockpit and GitLab is desirable.

• Experience with batch testing to run automatic test cases in a regression format.

• Strong written and verbal communication, judgment, decision-making, and critical thinking skills.

• Innovative mind for continuous learning and improvement.

• Bachelors (5+ years of experience) or Masters (3+ years of experience) in Computer Engineering/ Science, Electrical Engineering, Electronics Engineering or related fields.

Skills:

• Experience with Python or other scripting language in Linux/ Win OS is required

• Experience with analyzing requirements to develop automated test protocols.

• Experience with using test frameworks to generate events to the system under test.