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Using Engineering procedures standard for research and development, carries out assignments associated with research, design, development, support or manufacturing of specific parts, processes, software or components of medical diagnostic systems. Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications. Under the general direction of a functional manager, with moderate latitude for self-direction, operates in one or more areas of responsibility within a specific function.
Job Responsibility:
Lead testing activities including Software Feature Testing, Integration & System Testing, Regression Testing—covering UI, API, Functional, and Non-Functional testing (Performance, Load, Stress, Security)
Maintain a comprehensive traceability matrix to ensure full test coverage
Develop and maintain test frameworks, automation scripts, tools, test environments, and infrastructure
Conduct peer reviews of software requirements and design documentation
Review test cases, automation scripts, and test code for quality and accuracy
Assess existing test processes and recommend improvements to increase efficiency and effectiveness
Estimate, plan, and coordinate test activities while supporting ongoing testing efforts
Ensure compliance with internal design controls and applicable medical device regulations and standards (e.g., ISO 13485, IEC 62304, 21 CFR Part 820.30)
Lead a small testing team, delivering on key program milestones with a focus on timeliness and quality
Manage complex projects and multiple personnel simultaneously
Coach and mentor team members, supporting development through performance evaluation and leadership
Drive continuous improvement initiatives to enhance test processes, increase automation, and reduce cycle times
Collaborate closely with Software Developers, System Engineers, DevOps Engineers, and Scientists in an Agile/Scrum environment
Requirements:
Bachelor's degree in Engineering, Science or a related field
Ten years of product development or relevant experience
Six to eight years of product development or relevant experience for advanced degrees
In vitro medical device experience highly desired
Proficiency in English language required
Proficiency in Python and scripting languages such as Bash
Experience with test automation frameworks including PyTest and pytest-bdd
Hands-on experience with embedded device test automation
Familiarity with CI/CD tools: Jenkins, Docker, Git (Bitbucket/GitHub/GitLab)
Knowledge of BDD-based test development
Understanding of embedded software concepts: OS, APIs, gRPC, MQTT, etc.
Working knowledge of C++ and Java
Agile/Scrum experience
Proficiency with tools like DOORS, Jama, Jira, or equivalents
Quick learner with strong analytical and problem-solving abilities
Excellent communication skills—verbal, written, and presentation
Strong team player and collaborator
Passionate about emerging and disruptive technologies
Self-starter with a proactive mindset
Values transparency, trust, and a collaborative culture
Open-minded and eager to learn beyond current expertise
Process-oriented with a continuous improvement mentality