Description

You will support software testing and tool development for medical equipment development projects.

This role is on-site.

Responsibilities

• Plan, develop, and execute software testing to evaluate product verification status.
• Create and execute Design Verification Plans, protocols, and reports to identify and report software issues.
• Validate product software requirements, security requirements, and compliance standards.
• Collaborate with system, hardware, firmware, and QA/RA engineers in a distributed team environment.
• Support Automated Test Equipment validation and manage software-related CAPA.

Required Skills

• 3-8 years of experience in software testing and tool development for medical capital equipment.
• Minimum of 2 years of mandatory experience working with medical devices.
• Proficiency in manual testing, including risk assessment, protocol creation, execution, and report generation.
• Experience with Python or other scripting languages in Linux or Windows environments.
• Ability to analyze requirements to develop automated test protocols and use test frameworks to generate system events.
• Experience with measuring devices such as oscilloscopes and multimeters in a lab setting.
• Experience with batch testing to run automatic test cases in a regression format.
• Experience with Product Requirements and Risk Assessment.
• Bachelor's degree with 5+ years of experience or Master's degree with 3+ years of experience in Computer, Electrical, or Electronics Engineering.

Preferred Skills

• Proficiency in system testing with a hardware background.
• Experience creating DFH for FDA 510K/ISO 13485 submissions.
• Experience with Jira, Windchill, Cockpit, or GitLab.

Key Skills

Education

Bachelor's or Master's degrees