Senior Bioinformatics Quality Engineer

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At Exact Sciences, we’re helping change 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 Overview

The Senior Bioinformatics Quality Engineer I is responsible for ensuring the quality of the medical device software for IVD, IUO and LDT products. This entails executing verification and validation processes to ensure quality and compliance, as well as development and maintenance of software design controls for the products. The Sr Bioinformatics Quality Engineer I will be involved in testing, verification, and validation of the bioinformatics pipelines in all phases of system development.

Depending on the area of focus, the position is responsible for ensuring the creation, update and timely delivery of design controls or development and execution of verification and validation protocols.

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 cancer diagnostics. This role will work with software and bioinformatics teams to ensure development satisfies requirements, also guiding software changes to ensure adequate testing and compliance for IVD, IUO and LDT products. This position will be responsible for supporting software queries in audits.

With extensive science and/or engineering background, 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 is onsite at our San Diego location.

Essential Duties

Include, but are not limited to, the following:

• VERIFICATION AND VALIDATION
  • Develop and execute verification and validation protocols and generate test reports for multiple software solutions used in medical devices and LDT products.
  • Translate 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.
  • Work closely with bioinformatics scientists and operations to identify test inputs and provide technical guidance on the development of algorithmic test strategy, testing tools, and testing methodology.
  • Test product functionality and/or confirm product capabilities.
• DESIGN CONTROLS
  • Be accountable for design controls for medical device software and best practices for LDT software and create and manage all applicable documentation.
  • Participate in design feasibility assessments of medical device software.
  • 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.
• Mentor team members with a focus on software quality processes for regulated medical devices.
• Communicate documentation requirements to stakeholders across the organization.
• Institutionalize development best practices and evangelize test-driven development in the bioinformatics engineering team.
• Take part in audits, representing software activities and answering queries.
• 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, and evaluation criteria for obtaining solutions.
• Work on assignments individually and with project team members to meet department and project objectives.
• Work within project time frames with successful outcomes on multiple projects and key responsibilities.
• Exercise excellent team-working…