Work Schedule

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Job Description

JOB DESCRIPTION: 

Staff Engineer, Software V&V  

At Thermo Fisher, our mission is to cure cancer with genomic data. It is a close-knit, collaborative, cross-functional setting where we believe none of us is as smart as all of us and we each have something valuable to contribute toward our goal. The software services team is tasked with applying industry best practices to the design, development, and deployment of world-class software products. We are looking to hire individuals with experience with software development and test engineering in clinical and research settings, and who can help us solve the next wave of technical challenges using the latest cloud-based, big-data, and rich analytics toolsets. 

We are seeking enthusiastic Leader in Software Verification and Validation who will define scope, design, for automated and manual tests for highly advanced bioinformatics software. We require strong coding skills as well as a solid understanding of Quality Assurance principles and Continuous Integration methods. You will drive writing positive and negative smoke and regression test scripts to test product functionality and integration with dependencies. You will drive strategies for test APIs, user interfaces, web services, and/or web apps and write performance, load, and stress tests. 

You are excited and passionate about participating in an Agile/SCRUM setting to meet and exceed customer expectations and continuously drive towards quality improvements. You like the idea of partnering with users and other team members to brainstorm the best possible approaches to validating systems. You welcome the challenge of working in a fast-paced, discovery-oriented environment and will be genuinely excited about the prospect of creatively exercising your problem-solving skills continuously to ultimately improve the human condition. 

Essential Functions: 

• Develop and implement software testing Strategy, Methods and Best Practices that allow high quality NGS analytics and instruments software products to be designed, developed, and released into the regulated in-vitro diagnostics/ medical device space. 

• Lead and mentor a group of bioinformatics and software test engineers. 

• Establish software quality standards and KPI metrics to actively measure software and bioinformatics product quality. Implement software quality tracking tools and methodologies to provide on-going visibility and action during software product development lifecycle. 

• Single point of contact while working with external partners to deliver state of the art Software products in market. 

• Partner with software and bioinformatics leadership, functional and project managers to identify appropriate scope of software testing, verification and validation required for a project and managing the overall testing activities for projects. 

• Partner with internal and external stakeholders to drive the requirements for regulated assays and software. Help software development team to understand the complex informatics and visualization requirements leading into design implementation 

Minimum Qualifications (must have): 

• Masters/PhD preferred or Bachelors with minimum 08 years of work experience and strong track record of industry productivity 

• 08+ experience performing software verification and validation testing, preferably in the medical device/ biotech space 

• Strong understanding of NGS-based regulated software, IVD assay development practices and informatics data analysis pipelines. 

• Strong leadership abilities and extensive experience managing the activities of software quality engineering and assurance teams. Experience leading cross-functional, multi-site teams preferred. 

• Practical experience as a leader in the use of modern software development methodologies/ processes with an ability to direct the use of resources to meet department goals 

• Good understanding in design control for regulated products (e.g. US-IVD, IVD-D, IVD-R, China and Japan regulations) and knowledge of applicable regulations and standards used in IVD and medical device software development (e.g. ISO 13485, IEC 62304, and 21 CFR 820). 

• Ability to work well with senior leadership. 

• Experience working in a fast paced, dynamic environment.