Associate Director, Bioinformatics Quality Engineering
2 weeks ago
Exact Sciences Corporation
Associate Director, Bioinformatics Quality Engineering
Seattle ,
Washington
Apply Now
Help us change livesAt Exact Sciences, we're helpingchange how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you're working to help others.Position OverviewThe Associate Director, Bioinformatics Quality Engineering is responsible for leading the development and maintenance of software design controls associated with the development of medical device software for IVD, IUO and LDT products, and for successfully taking these products through verification and validation processes to ensure quality and compliance. This role will provide leadership to a team of Bioinformatics Quality and Systems Engineers by working to define clear and realistic goals and developing a general management view of the project. The position will participate in timeline development and in planning for new assignments/projects.Working in a team setting, this role will contribute to the implementation of new software solutions that process and interpret Next Generation Sequencing (NGS) data for the purpose of cancer diagnostics. As a subject matter expert, this position will guide development teams through software requirements for new products and manage changes to existing software to ensure compliance for IVD, IUO and LDT products. This position will be responsible for supporting software queries in audits. Working in a team setting, this role will be involved in investigating new technologies to improve and streamline the software development, testing and documentation processes.This role requires a strong focus on quality and attention to detail, and places high value on peer review, software testing and documentation. This position will join a geographically distributed team of highly motivated bioinformatics engineers at the forefront of cancer diagnostics and will be required to collaborate closely with scientists, IT and others creating these solutions.This position may be remote.Essential DutiesInclude, but are not limited to, the following:Lead the verification and validation efforts across multiple software solutions used in medical devices and LDT products.Oversee the translation of user and software requirements into executable software verification and validation protocols. This includes the full lifecycle focused on the creation of software requirements, hazard analysis, testing and validation.Be accountable for and own the processes for adherence to applicable regulations such design controls for medical device software and best practices for LDT software.Assess design feasibility and test product functionality and/or confirm product capabilities.Contribute towards the development of timeline and plan for new assignments/study/projects.Mentor team members with a focus on software quality processes for regulated medical devices.Communicate documentation requirements to stakeholders across the organization.Lead and participate in risk assessments for software products, including identification of potential risk mitigations and traceability to software requirements.Work closely with Regulatory and Quality to provide the appropriate level of software documentation, compatible with regulatory requirements.Institutionalize development best practices and evangelize test-driven development in the bioinformatics engineering team.Take part in audits, representing software activities and answering queries.Act as a leader and subject matter expert for one or more projects and in core team and/or cross-functional meetings.Work on problems of extremely complex scope in which analysis of data requires an evaluation of intangible variables.Exercise independent judgment in developing methods, techniques, a
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