Senior Bioinformatics Quality Engineer

At Exact Sciences, we help 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 for a purpose‑driven career, an inclusive culture, and robust benefits to support your life while you help others.

The Senior Bioinformatics Quality Engineer I is responsible for ensuring the quality of medical device software for IVD, IUO and LDT products. This entails executing verification and validation processes to ensure quality and compliance, as well as developing and maintaining software design controls for the products. The engineer will test, verify, and validate the bioinformatics pipelines throughout all phases of system development.

Depending on the focus area, responsibilities include creating, updating, and delivering design controls and executing verification and validation protocols.

Working in a team setting, this role contributes to implementing new software solutions that process and interpret Next Generation Sequencing (NGS) data for cancer diagnostics. The engineer works with software and bioinformatics teams to ensure development satisfies requirements and guides software changes for adequate testing and compliance for IVD, IUO and LDT products. The position also supports software queries in audits.
With extensive science and/or engineering background, this role focuses on quality, attention to detail, peer review, software testing and documentation. It requires collaboration with scientists, IT, and others in a geographically distributed team of bioinformatics engineers.

This position is onsite at our San Diego location.

• 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 verification and validation protocols, covering the full lifecycle focused on 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 methodology.
  • Test product functionality and confirm product capabilities.
• Design Controls
  • Accountable for design controls for medical device software and best practices for LDT software, creating and managing 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.
  • Collaborate 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 within the bioinformatics engineering team.
• Represent software activities and answer queries during audits.
• Analyze complex problems requiring evaluation of intangible variables.
• Develop independent methods, techniques, and evaluation criteria for solutions.
• Work individually and with project team members to meet department and project objectives.
• Deliver outcomes within project time frames across multiple projects.
• Demonstrate excellent teamwork, communication, and time‑management skills.
• Contribute to challenging goals in a fast‑moving environment.
• Uphold company mission, integrity, quality, and teamwork.
• Support and comply with the company’s Quality Management System policies and procedures.
• Maintain regular attendance.
• Model inclusion mindset and behaviors.
• Type 90% of the day on a computer or mobile device.
• Travel 10% between local Exact Sciences locations; travel 5% of working time away from work location, including overnight/weekend/international travel.

• B.S. Degree in Computational Biology, Computer…