Exact Sciences · 21 hours ago
Bioinformatics Quality Engineer I
San Diego, CA
Full-time
Onsite
New Grad, Entry Level
$80K/yr - $120K/yrExact Sciences is dedicated to changing how the world prevents, detects, and treats cancer. The Bioinformatics Quality Engineer I will support the quality assurance of medical device software through verification and validation processes, while collaborating with bioinformatics and software teams to ensure compliance and functionality of cancer diagnostic solutions.
BiotechnologyHealth DiagnosticsManufacturingMedical
Responsibilities
Help with verification and validation protocols and generate test reports for multiple software solutions used in medical devices and LDT products
Aid in translation of user and software requirements into executable software verification and validation protocols focusing on various aspects of the software lifecycle
Collaborate 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
Learn and apply best practices for LDT software and create and manage all applicable documentation
Participate in risk assessments for software products, including identification of potential risk mitigations and traceability to software requirements
Help with the creation of software documentation, compatible with regulatory requirements
Utilizing standardized procedures and practices, work on assignments individually and with project team members to achieve department and project objectives and meet deadlines
Exercise excellent verbal and written communication skills with the ability to communicate basic technical information
Work towards challenging goals in a fast-moving environment
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
Familiarity with the development of bioinformatics pipelines within Next Generation Sequencing and PCR applications
Familiarity with production software development lifecycle
Familiarity with best practices for software development (such as Git, agile, code reviews, CI/CD)
Ability to effectively communicate software system designs
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
Experience with programming languages, ideally Python
Familiar with automated software testing, preferably in the context of medical devices software such as bioinformatics analysis pipelines
Familiarity with container orchestration concepts and systems, e.g. Docker, Kubernetes, etc
Familiar working with cloud platforms (AWS, GCP, Azure)
Familiarity within an FDA-Regulated, Medical Device, Pharmaceutical, Biotech, or other regulated industry, developing CFR 21 Part 11 and IEC 62304 compliant software
Familiarity 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. as well as software audits is a plus
Familiar with managing requirements in a validated RM tool such as JAMA, DOORS, etc
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
Company
Exact Sciences
Exact Sciences offers a portfolio of cancer screening and diagnostic tests that span from early detection to treatment monitoring.
Founded in 1995
5001-10000 employees
H1B Sponsorship
Exact Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (33)
2024 (10)
2023 (19)
2022 (33)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$2.75B2025-06-20Acquired
2024-04-11Post Ipo Debt· $620.7M
2023-02-23Post Ipo Debt· $500M
Leadership Team
Kevin Conroy
Chairman & CEO
Aaron Bloomer
Executive Vice President, CFO
Recent News
2026-01-23
legacy.thefly.com
2026-01-23
Company data provided by crunchbase