Software Quality Engineer

Predicine is a global molecular insights company that is committed to advancing precision medicine in oncology. Predicine has developed a breakthrough cell-free DNA- and cell-free RNA-based liquid biopsy technology enabling minimally invasive molecular diagnosis for treatment selection, therapy monitoring, and minimal residual disease and early cancer detection. The company has launched a portfolio of blood-, urine- and tissue- based diagnostic assays for oncology.

Predicine partners with leading biopharma companies, institutions and government entities to support personalized healthcare on a global scale. www.predicine.com

Software Quality Engineer

We are looking for an experienced Software Quality Engineer to help us develop and implement our software test and validation strategy within a regulated environment. This role is key for ensuring the quality of our software systems, while meeting regulatory requirements for our products. In this position you ll get to work with an amazing group of engineers, scientists, and QA professionals to help make a real difference in the fight against cancer.

Here is what you'll get to do every day:

• Develop and implement software verification and testing systems and individual test cases for our commercial bioinformatics and lab software.
• Work with software and DevOps engineers to automate as much testing and deployment processes as possible, using tools such as GitLab and AWS.
• Develop and execute test plans and write individual tests both for single applications, integration testing, and full end-to-end testing.
• Write and deliver software and test documentation necessary such as IQ/OQ and regression testing to achieve and maintain compliance with FDA, ISO, and other regulatory and certification organizations.
• Work with Lab, Engineering, Regulatory, and Quality Assurance teams to define project requirements, design project plans, track project status, and report on progress.
• Advocate for Software Quality, DevOps, Security, and Agile best practices.

And experience we're looking for:

• Track record of successfully working with and developing effective software verification and test plans and infrastructure.
• Experience developing, writing, and editing clear and concise Software Development Lifecycle (SDLC) documentation, such as software requirements, risk assessments, and validation reports within a regulated medical device, healthcare, or biotech environment following ISO 13485 Design Controls.
• Professional experience in several programming languages, including Python.
• Experience working with databases, web apps, and command-line tools on a Linux system.
• Strong debugging and troubleshooting skills to identify the root cause of issues quickly in complex software systems.
• BS degree or higher in Computer Science, or equivalent training and experience.
• 6+ years of professional engineering experience.
• 4+ years of professional Quality Assurance, Test, or Regulatory experience.
• Bioinformatics or Next Generation Sequencing strongly preferred.
• High Performance Computing, AWS, and Docker experience is also a big plus.

Our Opportunity:

Salary Range for this position: 122K-188K

Candidate location: California, other locations may be considered.

All full-time roles in the US come with a robust benefits package which includes healthcare, dental, and vision insurance. Additional benefits include PTO, paid holidays and 401(k) retirement plan.

The posted salary range is the estimated base salary range for this position. Should the level or location of the role change during the hiring process, the applicable salary range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual s qualifications, location where the role is to be performed, internal equity, and alignment with market data.

We are proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities, and perspectives. Inclusive collaboration benefits our employees, our community, and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. All your information will be kept confidential according to EEO guidelines. We require all Predicine employee's to be fully vaccinated and provide proof of vaccination on their first day of work.

All job offers are contingent upon successful completion of background verification.

Applicants must be legally authorized to work in the USA.

We are not accepting third party resumes from recruiting agencies.