Sr. Bioinformatics Quality/Test Engineer

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At 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 Overview

The Senior Bioinformatics Quality Engineer I is responsible for leading the testing efforts for all software components of an end-to-end clinical assay. Responsibilities include overseeing the overall test strategy, planning, and release of all software components. This is a role within the scrum team, collaborating closely with Development and Product Owner leads to ensure a robust scrum and release process.

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 timeframes with successful outcomes on multiple projects and key responsibilities.
• Exercise excellent team-working skills with ability to complete collaborative projects on time and within budget.
• Exercise excellent verbal and written communication skills with the ability to communicate complicated ideas and information effectively at all levels.
• Work towards challenging goals in a fast-moving environment where on-time delivery of results is a high priority.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company's Quality Management System policies and procedures.
• Maintain regular and reliable attendance.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• Ability and means to travel 10% between local Exact Sciences locations.
• Ability to travel 5% of working time away from work location, may include overnight/weekend/international travel.

Minimum Qualifications

• B.S. Degree in Computational Biology, Computer Science, or field as outlined in the essential duties.
• 4+ years of experience spanning software quality engineering and medical device systems engineering and bioinformatics.
• Demonstrated deep understanding of and competence in the development of bioinformatics pipelines within Next Generation Sequencing and PCR applications.
• Knowledge of production software development lifecycle.
• Proven capabilities in creating verification and validation documentation, including GxP Assessments, Plans, Risk Assessments, Requirements/Design/Functional Specifications, IQ/OQ/PQ Protocols, Reports, Traceability Matrix, and Standard Operating Procedures.
• Understanding of best practices for software development (such as Git, agile, code reviews, CI/CD).
• Ability to effectively communicate software system designs.
• Experience working within a Quality Management System.
• Excellent communication skills (both written and oral) with the ability to communicate complicated ideas and information effectively at all levels.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.

Preferred Qualifications

• Master's or Ph.D. degree is preferred.
• Polyglot background in programming languages with fluency in Python.
• Experience with automated software testing (unit, integration, system) preferably in the context of medical devices software such as bioinformatics analysis pipelines.
• Familiar with container orchestration concepts and systems, e.g. Docker, Kubernetes, etc.
• Familiar working with cloud platforms (AWS, GCP, Azure).
• Experience within an FDA-Regulated, Medical Device, Pharmaceutical, Biotech, or other regulated industry, developing CFR 21 Part 11 and IEC 62304 compliant software.
• Experience with medical device requirements such as Quality System Regulation (21 CFR part 820) ISO 14971 Medical Device Risk Management, ISO 13485, etc. Work experience is strongly preferred.
• Familiarity with bioinformatics analysis pipeline frameworks.
• Familiarity with software related Cybersecurity risk management such as FDA Cybersecurity guidance, IEC27000 series, IEC 15408, etc.
• Experience with PAI, ISO and MDSAP audits is a plus.
• Experience managing requirements in a validated RM tool such as JAMA, DOORS, etc.

Salary Range:

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits.

Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.

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