The Software Quality Staff Engineer is the champion for creating, implementing, and sustaining Freenome's Software Development Lifecycle. As a cross-functional leader, this role is responsible for coaching Software Engineers and Computational Researchers in best practices for software development and validation, ensuring compliance with international standards and regulations.
Create, implement, and improve an IEC 62304:2006 compliant SDLC program with the Software Engineering and Computational Research teams.
Design and implement test plans, test cases, test automation
Create, implement, and improve a Computer Systems Validation (CSV) program with Software Engineering and IT teams.
Coach and educate software developers and engineers from diverse backgrounds (tech, biotech, and academia).
Develop, maintain, and publish plans to test custom-developed and COTS/SaaS applications that include assignment of staff, estimated effort and time frame to complete testing
Organize and facilitate sprint planning, daily stand-up meetings, sprint reviews, retrospectives, release planning, sprint demos and other Scrum-related activities.
Generate test reports and product quality metrics.
Support and contribute to the growth of Freenome's Quality function by participating in other Quality Systems projects as needed.
What We're Looking For:
Energetic expert in IEC 62304 and GAMP5.
Well-versed in ISO 13485:2016 and 21CFR820.
Proven track record of building and implementing Quality processes for software teams.
Proven track record of participating/leading software development initiatives from concept to market.
Positive and dynamic servant-leader who can both strategically lead teams and roll up sleeves to complete tasks.
5+ years in a regulated life sciences company.
2+ years of experience managing direct reports.
2+ years of formal or informal experience in project management.
Nice to Haves:
Experience with in vitro diagnostic devices (IVD).
Experience with Software as a Medical Device (SaMD).
Experience with Artificial Intelligence/Machine Learning.
Experience with Software/IT Quality in Clinical Laboratories (CLIA, CAP, NYSDOH & ISO 15189:2012).
Experience with Information Security Management Systems.
Freenome is on a mission to empower everyone with the tools they need to detect, treat, and ultimately prevent diseases.
By applying advanced machine learning techniques to recent breakthroughs in genomic science, Freenome is developing simple blood tests to detect early-stage cancer and make treatments more effective. The company has raised $238 million from investors such as RA Capital, Polaris Partners, Perceptive Advisors, Andreessen Horowitz, funds and accounts advised by T. Rowe Price Associates, Inc., GV (formerly Google Ventures), Roche Venture Fund, Kaiser Permanente Ventures, American Cancer Society's BrightEdge Ventures, Data Collective Venture Capital, and Verily Life Sciences (formerly Google Life Sciences).
Freenome is building technology to gain an understanding of the body through several analytes derived from blood. These signals include cell-free DNA, methylation of cell-free DNA, cell-free RNA, circulating proteins, and immune profiling derived from thousands of prospective samples. By developing novel statistical learning methods and applying them to integrate various -omics datasets, Freenome is a leader in modeling specific biological mechanisms to capture disease dependent signatures such as gene expression, immune response, tumor burden, the tissue of origin, and 3D chromatin structure.
By building comprehensive discovery datasets and modeling critical biological systems, Freenome is learning what biological changes are present within the blood between a variety of different disease states including cancer, autoimmune disorders, infections, drug response, and aging. With the combination of Freenome's datasets, cross-functional technical expertise, and mission to uncover the biological truth, we seek to positively change the lives of millions through the early detection and early treatment of disease.
Freenomers are technical and creative, visionary and grounded, empathetic and passionate. We build teams around divergent expertise, which allows us to solve problems and uncover opportunities in unique ways. Freenomers are some of the most talented experts in their fields, coming together to advance healthcare one breakthrough at a time.
We value empathy, integrity, and trust in one another. That means embracing other's perspectives, those of our coworkers and those of the patients and communities we serve. It means knowing when to push, and when to listen. At Freenome, we give each other the benefit of the doubt in the belief that we're all working as a team toward the same goals, and empower others to grow in a collaborative environment.
What does a successful person look like at Freenome?
Those who thrive at Freenome prioritize, manage, and execute their own goals in alignment with those of the company. They embrace our values of empathy, integrity, and trust, and hold themselves and their team accountable. They crave collaboration with brilliant minds from unfamiliar fields of study and believe that hiring and mentorship are fundamental to our success. Above all, they welcome and provide constructive feedback and criticism, trusting in the good intentions of others, and secure in the knowledge that embracing mistakes is the best way to learn and move on. For those who crave challenges, understudied problems, and the chance to see their work impact the lives of millions of people affected by cancer every year, there's no better place to be.
Freenome explicitly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status.