Responsibilities:

•  Troubleshoot software anomalies
• Work with a team of test engineers on medical devices and equipment
• Coordinate between various groups to ensure software testing meets all requirements.
• Identify and evaluate software risks and risk mitigations.
• Write regression and user-interface test cases.
• Develop understanding of user workflow to create, document, and execute test plans.
• The tester must quickly become expert on system functionality and that of various peripheral devices as well as the requirements that drove system design.
• May be asked to create tests for ad hoc situations such as replicating field-reported problems or load testing under specific conditions.
• With minimal guidance create test environments that mirror a multitude of installed baselines.
• Implement test processes on projects, write test plans/cases, procedures and scripts, and analyzes test results.
• Perform functional testing Ensure all systems are running according to necessary specifications and operate within regulations to ensure the production of quality products
• Establish validation standards and develop testing protocols
• Prepare validation and performance qualification protocols for new and/or modified processes, systems or equipment for medical devices.
• Author technical documents (protocols, reports, standard operating procedures) to comply with regulatory requirements

  Qualifications:

• BS/BA degree in any of the following computer science, software engineering, electrical engineering, biomedical engineering, or mathematics required
• Minimum 3-5 years’ experience in software development and/or testing of embedded medical device
• 3-5 years as a software and hardware system tester, integrator, or developer.
• Must have sufficient software/ hardware experience to build and configure workstations, understand the subsystems and their interactions in an overall system.
• Proficient with identifying and writing up software defects for software developers
• Programming experience with scripting languages (Perl, batch, PowerShell)
• Experience with Windows and exposure to WinCE based devices.
• Proficient with the characterization of software anomalies
• Experienced in software verification and validation strategies.
• Experienced in Implementing test processes on projects, write test plans/cases, procedures and scripts, and analyzes test results.
• Strong analytical and problem-solving skills is a must
• Strong oral and written communication skills
• Must work well in a team environment, be highly motivated, and willing to learn new skills.
• Good communications and documentation skills, including experience in writing SOPs, work instructions, training and other relevant documentation.
• Experience working with manufacturing, development and production teams or groups.
• Previous experience with testing in a medical device manufacturing environment subject to FDA compliance is a plus.

Required:

• Degree in computer science/engineering preferred.
• Will consider other STEM degrees. 3-5 years’ experience with testing/developing software for a medical device.
• Experience testing class II/III medical device software.
• Experience with Windows applications and embedded firmware.