Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients worldwide. This client is a German multinational Pharmaceutical and biotechnology company and one of the largest pharmaceutical companies in the world headquartered in Leverkusen and areas of business include pharmaceuticals; consumer healthcare products agricultural chemicals seeds and biotechnology products.
Job Title: Software V&V Engineer Testing
Location: Indianola PA 15051
Duration: 6 Months
Job Type: Contract
Work Type: Onsite
Job Description:
POSITION DUTIES & RESPONSIBILITIES
- Verification and Validation of software for complex system interactions in medical devices including
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Application software
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Embedded software
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Platform software
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Operating system software
- Development and execution of manual and/or automated software verification protocols including:
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Requirement analysis and review
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Architect test strategy
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Design and development of test scenarios
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Authoring Review and execution of test cases and protocols
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Authoring Review and execution of automated test scripts
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Analyzing results tracking discrepancies and writing reports
- Responsible for verification of the software platform of the medical device including:
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User interface and interactions
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Performance and reliability
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Safety and interoperability
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Compliance with standard operating procedures for medical device development including compliance with ISO 13485 and IEC 6230
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Critical analysis of technical situations identifies problems and work with the crossfunctional team in resolving the problems.
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Collaborating within crossfunctional teams across multiple geographies to convey problems opportunities solutions and results in medical device R&D activities
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Engaging in continuous improvement initiatives to establish Center of Excellence (CoE) in Software Assurance function
REQUIREMENTS/PREFERENCES
Skill & Competency Requirements:
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Bachelors degree in Engineering preferably Computer Electronics Electrical
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Minimum of 5 years or more experience in automated test script development and execution
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Experience with python programing / scripting is a must
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Experience with Automation framework development.
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Technical writing ability clear and concise writing easily understood by multiple audiences (testers auditors peers etc.)
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Ability to work inoffice all days of the week
Preferences:
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Experience designing and developing medical device software in a regulated environment while adhering to FDA Design Controls and software process guidelines for medical devices including ISO 13485 and IEC 62304
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Working knowledge of tools such as Rational Quality Manager Jenkins Squish TOSCA JIRA Git and DOORS Next Gen
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Working knowledge on OS such as Windows Linux flavors
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Demonstrated ability working in a matrix/hybrid organization structure
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Ability to troubleshoot and make quick knowledge and experienceguided decisions
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Excellent written and oral communication
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Excellent people skills ability to partner well good team camaraderie
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Proficient with Microsoft Office tools especially MS Word MS Excel MS PowerPoint MS Project and other management tools
TekWissen Group is an equal opportunity employer supporting workforce diversity.