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Exact Sciences · 21 hours ago

Senior Bioinformatics Quality Engineer

US - CA - San Diego

Full-time

Onsite

Mid, Senior Level

$128K/yr - $192K/yr

4+ years exp

Exact Sciences is helping change how the world prevents, detects, and guides treatment for cancer. The Senior Bioinformatics Quality Engineer I is responsible for ensuring the quality of medical device software, executing verification and validation processes, and collaborating with bioinformatics teams to implement software solutions for cancer diagnostics.

BiotechnologyHealth DiagnosticsManufacturingMedical

No H1B

Responsibilities

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

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

Qualification

Bioinformatics pipelinesVerificationValidationMedical device softwareSoftware quality engineeringNext Generation SequencingTest automation toolsAgile methodologiesCommunicationTeam collaborationMentoring skills

Required

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

Applicants must be currently authorized to work in country where work will be performed on a full time or part-time basis. We are unable to sponsor or take over sponsorship of employment visas at this time

Preferred

Experience designing and implementing automated testing frameworks for bioinformatics pipelines and applications, including proficiency with test automation tools (e.g., Selenium, pytest, or similar) and CI/CD integration for continuous testing of genomic data workflows

Familiarity with AI/ML technologies and their applications in software testing and quality assurance, including experience evaluating or implementing AI-driven solutions for test optimization, defect prediction, or quality improvement initiatives

Experience mentoring junior engineers through technical guidance, paired programming, and structured code reviews, fostering knowledge sharing, best practices adoption, and continuous improvement within the software quality and bioinformatics engineering teams

2-5 years of experience in software testing, NGS bioinformatics pipelines, and test automation

Familiarity with working in an SDLC/Agile/Scrum environment