Engineer II Software Test

• 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.
• Effectively work on established software quality standards and KPI metrics to actively help measuring software and bioinformatics product quality.
• Work with Leads to implement software quality tracking tools and methodologies to provide on-going visibility and action during software product development lifecycle.
• Effectively work with Leads 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 4-6 years of work experience and strong track record of industry productivity
• 04+ 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.
• 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.