Position Details
Software V V Engineer Testing Apply
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. 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
Department/Team Description:
- Radiology Software Assurance & Operations Team.
- Primary Function: System software verification and validation of radiology device products to meet FDA design controls
Position Summary:
- This position will be responsible to perform software verification and validation of medical devices to deliver a high-quality product that meets or exceeds customer expectations and meets FDA design controls.
Position Duties and Responsibilities:
- Verification and Validation of software for complex system interactions in medical devices, including:
- Application software
- Embedded software
- Platform software
- Operating system software
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- Development and execution of manual and/or automated software verification protocols, including:
- Requirement analysis and review
- Architect test strategy
- Design and development of test scenarios
- Authoring, Review and execution of test cases and protocols
- Authoring, Review and execution of automated test scripts
- Analyzing results, tracking discrepancies, and writing reports
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- Responsible for verification of the software platform of the medical device, including:
- User interface and interactions
- Performance and reliability
- Safety and interoperability
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- Compliance with standard operating procedures for medical device development, including compliance with ISO 13485 and IEC 62304
- Critical analysis of technical situations, identifies problems, and work with the cross-functional team in resolving the problems.
- Collaborating within cross-functional teams across multiple geographies to convey problems, opportunities, solutions, and results in medical device R&D activities
- Engaging in continuous improvement initiatives to establish Center of Excellence (CoE) in Software Assurance function
Requirements/Preferences:
Skills & Competency Requirements:
- Bachelor's degree in Engineering, preferably Computer, Electronics, Electrical
- Minimum of 5 years or more experience in automated test script development and execution
- Experience with python programing / scripting is a must
- Experience with Automation framework development.
- Technical writing ability clear and concise writing easily understood by multiple audiences (testers, auditors, peers, etc.)
- Ability to work in-office all days of the week
Preferences:
- 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
- Working knowledge of tools such as Rational Quality Manager, Jenkins, Squish, TOSCA, JIRA, Git and DOORS Next Gen
- Working knowledge on OS such as Windows, Linux flavors
- Demonstrated ability working in a matrix/hybrid organization structure
- Ability to troubleshoot and make quick knowledge and experience-guided decisions
- Excellent written and oral communication
- Excellent people skills, ability to partner well, good team camaraderie
- Proficient with Microsoft Office tools especially MS Word, MS Excel, MS PowerPoint, MS Project, and other management tools
TekWisen Group is an equal opportunity employer supporting workforce diversity.
