Exact Sciences is the developer and manufacturer of Cologuard, a non-invasive screening test for the early detection of colorectal cancer. The Bioinformatics Quality/Test Engineer II is responsible for leading the testing efforts for all software components of an end-to-end clinical assay, overseeing the overall test strategy, planning, and release of software components.
Help with 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 focusing on various aspects of the software lifecycle.
Collaborate closely with bioinformatics scientists and operations to identify test inputs and understand the development of algorithmic test strategy, testing tools, and testing methodology.
Test product functionality and/or confirm product capabilities.
Help with design controls and appropriate software documentation (e.g. software requirements and/or specifications, architecture documents, software design details doc) for medical device software lifecycle.
Follow 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.
Provide the appropriate level of software documentation, compatible with regulatory requirements.
Communicate documentation requirements to stakeholders.
Participate in audits, representing software activities and answering straightforward queries.
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.
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.
Qualification
Required
B.S. Degree in Computational Biology, Computer Science, or field as outlined in the essential duties.
2+ years of experience spanning software quality engineering and medical device systems engineering and bioinformatics.
Familiarity with the development of bioinformatics pipelines within Next Generation Sequencing and PCR applications.
Familiarity with production software development lifecycle.
Experience 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
Bachelor’s/Masters degree in Bioinformatics, Bioengineering, Computer Science, or a related field.
2-5 years of experience in software testing, NGS bioinformatics pipelines, and test automation.
Familiarity with working in an SDLC/Agile/Scrum environment.
Benefits
Paid time off (including days for vacation, holidays, volunteering, and personal time)
Paid leave for parents and caregivers
A retirement savings plan
Wellness support
Health benefits including medical, prescription drug, dental, and vision coverage
Exact Sciences is the developer and manufacturer of Cologuard, a non-invasive screening test for the early detection of colorectal cancer.
