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- Create and update project documentation such as requirements (software, hardware, and system), traceability matrices, test plans, protocols and reports
- Apply systems analysis techniques and procedures, including consulting with clients, to determine and create hardware, software and/or system functional requirement specifications
- Interface with client, project lead, software and hardware design engineers to ensure that key system level features function as expected
- Create, execute and document formal verification testing (software, hardware, and system) on state of the art medical devices (embedded real-time systems, PC based systems, smartphone based systems, and Web based systems)
- Perform black box integration, system, and regression testing
- Trace effectiveness of verification activities based on traceability matrices
- Utilize commercial off-the-shelf software test tools to support the design and development of medical devices
- Work with team on the development of risk analysis and FMEA documentation
- Work with team members to understand, profile, and estimate complexity for project deliverables
- Estimate effort and resources required for requirements and verification activities and actively work towards improving accuracy of personal estimates in comparison to actual work effort performed
- Bachelor’s Degree in Computer Engineering, Electrical Engineering, or Biomedical Engineering, or similar discipline
- 0-3 years’ experience in software and/or hardware testing
- Basic experience with the software development life cycle
- Basic experience with test equipment/test tool design and implementation including the appropriate levels of qualification
- Experience debugging using emulators and electronic test equipment
- Experience ad-hoc testing is a must
- Experience with medical device development under quality systems
- Experience with Source Code Management, Requirements Management, and Defect Tracking systems
- Experience with RTOS and embedded firmware programming techniques
- Experience providing written reports, test protocols, and engineering documentation for testing of medical devices
- Experience with black-box and white-box testing
- Experience with automated testing
- Knowledge of and ability to work within safety related quality process is a plus: FDA, FAA (DO-178B), DOD, etc.
- Experience with C, C, Visual Basic, and assembly a plus
- Ability to write requirement specifications and test plans and protocols are a must
- Good knowledge of ISO 13485/14971, 93/42/EEC, 90/385/EEC, EN45502, EN60601-1, EN61000
- Good knowledge of System Engineering principles, current technologies, and product test techniques
- Good written skills to document concise and detailed S/W and H/W defects
- Good verbal, written and interpersonal communication skills
- Good documentation skills and attention to detail
- Good ability to execute test protocols, log and track defects to closure, collaborate with team to resolve
- Good ability to analyze and resolve non-routine product, testing, and/or test equipment/tool issues using independent judgment
- Good ability to develop unit test protocol (not mandatory)
- Excellent analytical skills
- High level of initiative with ability to self-manage
- Strong interpersonal skills with ability to work both independently and as part of a team
- Excellent written and verbal communication skills
- Ability to perform white box/unit testing is a big plus
- Ability to diagnose and repair hardware issues is a big plus
- ID: #21166497
- State: New Jersey Moonachie 07074 Moonachie USA
- City: Moonachie
- Salary: Open
- Job type: Permanent
- Showed: 2021-10-15
- Deadline: 2021-12-04
- Category: Et cetera