Senior Software Quality Engineer

About Freenome

Freenome is a high growth biotech company on a mission since 2014 to create tools that empower everyone to prevent, detect, and treat their disease. To achieve this mission, Freenome is developing next-generation blood tests to detect cancer in its earliest, most treatable stages using our multiomics platform and machine learning techniques. Our first blood test will detect early-stage colorectal cancer and advanced adenomas.

About the Role

Freenome's Senior Software Quality Engineer will support the company's quality and regulatory activities with various authorities, including FDA, CLIA, CAP, and the NYSDOH, and quality systems, GMP, IVDR, and ISO. Working with the cross-functional team of Engineering, Regulatory Affairs and Quality, you will be responsible for supporting regulatory and quality leadership, vision and direction for premarket and postmarket activities for the software products under development.

Your contribution:

The Senior Software Quality Engineer is an integral member of Freenome's QA/RA team. You'll make a significant contribution to our mission of empowering everyone with the tools they need to detect, treat, and ultimately prevent cancer. In this strategic and tactical role, you will support software quality engineering initiatives; including Software Development Lifecycle (SDLC) processes, Software Requirements/Design/Algorithm Analysis, Software Validation, Software Risk Management, Software Defect Tracking, among others. The following list details the core focus and responsibilities:

• Support development of SDLC processes under the quality management systems necessary for compliant software development, validation and verification, including processes for product maintenance, defect tracking and change control management
• Participate in engineering reviews of software requirements analysis, architecture/design review, algorithms analysis, code reviews
• Execute company strategies for all software activities for all products and services. Support software based Q-submissions and/or sprint discussions
• Support health authority submissions, including US FDA applications, and agency communications for CRC screening test and associated software
• Work with Freenome team on regulatory and quality strategies and their execution, especially in support of software products and associated components
• Support risk management for software both in pre-market and postmarket capacity
• Support software defect tracking and monitoring with engineering
• Provide support during inspections and audits, leading those related to software products

Your background, perspective and experience:

• Minimum degree requirement: Bachelor of Computer Sciences, Computer Engineering, or relevant disciplines such as Regulatory Affairs, Bioengineering or Data Science
• 7+ years in a regulated life sciences company, in particular medical devices
• Knowledge of Software Quality Engineering fundamentals, including software requirements analysis, architecture, code review/static analysis, hazard/risk analysis, software test, among others
• Knowledge of FDA's regulations, guidance documents and recommended consensus standards
• Energetic expert in IEC 62304
• Well-versed in ISO 13485 and 21 CFR Part 820
• 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, including verification and validation
• Positive and dynamic servant-leader who can both strategically lead teams and roll up sleeves to complete tasks

The followings are nice-to-have and will certainly make your qualification a big-plus:

• Experience with in vitro diagnostic devices (IVD) development
• Experience with Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD)
• Experience with test automation software development

COVID safety:

As a condition of employment, you agree to know and comply with our COVID-19 vaccination policy requiring all employees who work on-site and/or attend work-related events to be fully vaccinated and to receive a COVID-19 booster once eligible. Company employees working on-site are required to be fully vaccinated for COVID-19 and to receive a COVID-19 booster once eligible, unless a reasonable accommodation is approved or as otherwise required by law. Absent a reasonable accommodation or legal exception, you agree to provide proof of your vaccination status and to be fully vaccinated by your first day on-site, in accordance with our policy. If you are currently eligible for a COVID-19 booster, you also agree to provide proof of having received a booster. If you are not yet eligible for a COVID-19 booster, you must provide proof of receiving a booster within two weeks of becoming eligible.

Freenome is proud to be an equal opportunity employer and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Funding

We have raised more than $1.1B from leading investors including Perceptive Advisors, RA Capital Management, Roche Venture Fund, Kaiser Permanente, Novartis and the American Cancer Society's BrightEdge Ventures.

Freenomers

A 'Freenomer' is a mission-driven employee who is fueled by the opportunity to make a positive impact on patients' lives, who thrives in a culture of respect and cross collaboration, and whose work makes a significant impact on the company and their career.

Freenomers are technical, creative, visionary, grounded, empathetic and passionate. We build teams around divergent expertise, allowing us to solve problems and ascertain opportunities in unique ways. Freenomers are some of the most talented experts in their fields, joining together to advance healthcare, one breakthrough at a time.

Benefits include but are not limited to:

• Competitive compensation
• Pre-IPO equity
• Flexible PTO (exempt) and generous PTO (non-exempt)
• Comprehensive health coverage, including medical, dental, and vision
• Wellness and mental health resources, including Employee Assistance Programs (EAPs), Paid maternity and paternity leave
• 401(k) plan
• $250.00 new hire stipend to enhance your home office experience
• Plus, a variety of other perks, including pre-tax commuter benefits, two paid volunteer days per year, pet insurance, and additional discounts

Applicants have rights under Federal Employment Laws.

• Family & Medical Leave Act (FMLA)

• Equal Employment Opportunity (EEO)

• Employee Polygraph Protection Act (EPPA)

Notice to agencies:

Our in-house Talent Acquisition Team manages all employment opportunities at Freenome. Agencies and independent recruiters must be approved as a vendor by Freenome's Talent Acquisition team before submitting candidates to any Freenome employee.

We do not accept unsolicited resumes or biographies from agencies under any circumstances. Any unsolicited resumes sent to Freenome, including those sent to a Freenome email address or directly to Freenome employees, will be considered Freenome property. Freenome will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Freenome will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees.

Please do not contact Freenome employees directly. Compliance with this request will impact our decision to work with you.

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