Job Details

Can you please confirm your top 3 skills sets required?

1. 1. System-Level Test Design,  Troubleshooting, and V&V (hardware, software, sensors, controls, networking, safety systems).
   2. Quality & Regulatory Compliance (IEC 62304)
   3. Python Test Scripting

Can you please confirm the 3 main responsibilities/day to day activities required for this role?

1. 1. Plan and Execute Verification & Validation Testing ( Manual & Automated)
   2. Identification, Investigation, and documenting defects 
   3. Test report creation and regulatory complaince for V&V for capital equipment

What products (if any) will this role support?  Affera Mapping & Ablation System 

What is your target years of experience?  3+ years (4 years experience required for a Senior level role)

When do you plan to start interviewing?  ASAP

Will you be looking to hire and start ASAP or will the start date be delayed?  ASAP

Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)?  4 days onsite is required, 1 day remote.

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Primary Responsibilities

·       Test the functionality and performance of the systems software

·       Develop and execute manual test plans and scripts designed to detect problems

·       Ensure systems software meets technical and functional requirements

·       Perform workflow analysis, document test results and recommend quality improvements

·       Work with engineers to resolve software defects and diagnose/improve product configuration for current and future models.

Preferred Qualifications

·       Expert knowledge of Medical Product verification, IEC-62304 and FDA guidance in a technical discipline, preferably software related (Computer Science, Computer Engineering, Electrical Engineering)

·       Experience debugging hardware with tools such as oscilloscope and function generators

·       Experience writing, executing, and maintaining test automation scripts in Python or a comparable language. Experience should include automating functional, regression, and system-level test cases; working with test frameworks and reusable test libraries; analyzing logs and test results; debugging failures; and integrating automated tests into the broader verification workflow.

·       Experience writing technical reports

·       Experience using a tool or repository for managing test cases (Polarion, TFS, TestRail, JAMA etc

·       Strong work ethic and entrepreneurial drive

·       Ability to work with Systems, Mechanical, Electrical and Software engineers when discovering, documenting, and resolving integration issues.

·       Ability to work with QA to ensure testing meets Quality and Regulatory needs.

·       Ability to work effectively in a fast-paced, collaborative environment.

·       Strong communication skills, both written and verbal