What are the responsibilities and job description for the Validation & Verification Tester position at Trail Blazer Consulting LLC?
Job Details
Role: Validation & Verification Tester
VISAs: USC/-EAD/OPT
Location: Bedford, NH
Schedule: Hybrid in Bedford, NH, with some travel to Marlborough, MA
Interview Mode: Virtual
Duration: 3 Month Contract
Experience Required: 5 years
JOB DESCRIPTION:
Looking for a versatile individual with deep skills and experience in medical device development to participate in product development, product verification and perform compliance activities.
MUST HAVE:
- 3-4 years experience with 1-2 roles medical device environment
- Experience with writing verification procedures, execution and reporting on the verifications
- Knowledge and understanding of medical device regulatory requirements (doesn t need EUMDR)
Project: Verification and Validation work for Medical Device Company in Marlborough MA & Bedford, NH
- Execute verification and validation testing of software and hardware for Class III medical devices (high-risk devices, aka ventilators, pacemakers, heart valves, etc)
- Take the requirement, review it for testability, write steps to test it, group the test steps into logical protocols, execute the protocol once approved and create the test record for the results
- Update existing test protocols, including hardware protocols that require knowledge of how to use an oscilloscope and then execute the tests and record the results
- Systems-level testing, mix of software and hardware
Responsibilities
- This person will ramp up on system operation, supporting verification team, execute different verification test cases, work on the scope, develop scope, verifying
- They will be working with the Test Leads for TIG device, as the Test Lead manages this and drives the workload.
- Would be working with the Lead and a Software Engineer, providing feedback
- The process is fixing and providing response, working on the features, then formal execution, software will then be complete then this person will officially test it and ensure operates as expected
- They leverage DOORS (RQM) which is management tool and they draft test cases in,
- This person will be looking at the requirement, executing that test cases and providing results
Salary : $55