Who we want
Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
What you will do
We are looking for a passionate software engineer who can play a critical role in the Test Development area of our product development ecosystem. Responsible for creating plans for verification testing, test procedures and process development for testing medical devices in accordance with internal development procedures. The position requires creating and implementing testing methods, recording the test results and prepare test matrices. This engineer is responsible to test all aspects of the product/system like function/component, system, performance, regression and service. They need to possess strong analytical skills and ability to formulate test documentations such as testing protocols and test reports.
Key Areas of Responsibilities:
- Design, develop, modify, evaluate and verify software components for medical devices.
- Learn procedures, policies, processes, systems and technology required.
- Interpret customer needs and understands design inputs.
- Create or maintain engineering documentation, such as design requirements or system specifications.
- Develop system level verification strategies and may lead test development of components and sub-systems.
- Software build, change control, and development/test process improvement.
- Acts as the test development lead for a project, providing verification strategies and product content guidance.
- Collaborate with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success.
What you will need
- Bachelor’s or Master’s Degree in Software or Electrical Engineering, Computer Science or other related technical degree required
- Minimum 4 years’ working experience in engineering, R&D, software, designing or testing
- Exposure to programming skills in C/C++, Python
- Use of integrated development environments (IDE) Eclipse, KDS for projects
- Using tools such as Parasoft for static/dynamic analysis, memory management, code coverage and techniques for analyzing software
- Integration and deployment processes using Jenkins
- Generate and review the necessary documents with project teams (requirements/design/architecture/bugs/test)
- In code reviews applying design principals, coding standards and best practices
- Demonstrated experience in software testing methods, test plan and test case development
- Software Development Life Cycle processes such as Agile, Waterfall
- Application Lifecycle Management /Traceability tools such as Cockpit
- Code development time/resource estimation to support projects
- Regulatory and compliance standards applied to the SDLC (Software Development Life Cycle) such as IEC62304
- Understand fundamental industry standards, design requirements and test strategies which align with regulatory requirements
- Experience with verifying and validating software products in an FDA environment or other regulated industry
- Experience with LabView, Veristand for test frameworks
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