Actalent Sr. Software Validation Engineer in Inglewood, California
Essential Duties and Responsibilities • Lead the Software Verification and Validation (V&V) activities for product software, QMS software, ERP and MES software, automated equipment, etc. • Design, implement and execute software V&V test protocols/test cases at system level, integration level and unit level. • Develop software test tools for software V&V as needed. • Write software V&V reports and resolve software V&V deviations. • Lead the software risk management activities, e.g., software risk management plan, hazard identification, risk analysis, mediation controls, and software risk management reports. • Establish traceability between requirements, risk analysis and test cases. • Review system and software requirements to ensure testability and completeness. • Partner with key stakeholders (e.g., R&D, Manufacturing, Quality & Regulatory, and IT) to drive testing and validation strategies, improve productivity, maintain compliance, and meet the project timelines. • Provide expertise in testing principles and methods to drive robust testing, validation, and support of technical solutions. • Guiding team members and partner with vendors to develop and document test strategy, scenarios, and protocols. • Ensure software V&V activities comply to regulations and meets intended use. • Communicate project updates and progress to management. • Additional projects and/or duties as assigned Qualifications Required for Position • Bachelor’s degree in Computer Science, Software Engineering, Computer Engineering, or similar disciplines with 10 years of experience in Software Quality, testing, verification and validation in FDA regulated industries; OR Master’s degree in same disciplines with 8 years of experience in software Quality, testing, verification and validation in FDA regulated industries. • Hands-on experience with software V&V methodologies, processes & practices for software V&V, as well as troubleshooting. • Hands-on experience with Software Development Life Cycle. • Experience testing software systems. • Experience testing medical devices that contain embedded software. • Experience with MES and/or other manufacturing applications. • Experience with testing software, software quality and test protocol development • Strong familiarity with FDA regulations and guidance for software validation. • Strong familiarity with IEC 62304 standard. • Strong familiarity with ISO 14971 risk management standard. • Strong familiarity with FDA’s Cybersecurity requirements. • Ability to work well in a fast-paced environment.
Validation testing, risk assessment, medical device, linux, c, c++, python, software testing, Validation, Quality assurance, Test automation
Top Skills Details:
Validation testing,risk assessment,medical device,linux,c,c++,python,software testing
Additional Skills & Qualifications:
Desired skills and traits • Experience with Oracle Agile PLM/QMS software configuration, implementation, software V&V is preferred. • Someone who gets things done without perfect resources, is innovative, and works with a sense of urgency. • Results oriented – drives progress & excellence. • Ability to work independently with minimal supervision. • Effective interpersonal and communication skills. • Well organized and attentive to detail. • Contributes to a collaborative and inclusive work environment. • Has a sense of urgency and a willingness to get to the bottom of a problem. • Someone who has high standards, takes ownership, and is invested in the outcome. • Someone who proactively helps others, stays positive and has a good sense of humor.
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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