Back to Job Listings

Software Quality Engineer - CTS

Boston, MA or Remote

At PathAI, we are using machine learning to diagnose disease accurately and to match patients with effective therapies. We develop and apply computational methods to integrate data across biological scales (population, patient, tissue, cellular, molecular and genomic) to define disease states and to predict therapeutic response. Clinical Trial Services play a central role in this effort. We are looking for a Software Quality Engineer to support these efforts at PathAI. If you are the right candidate, you will strategically partner with Machine Learning, Engineering, and Clinical Trial Services Operations to develop, monitor, validate, and audit the operations and deliverables involved in clinical trial services at PathAI.

The successful Software Quality Engineer - Clinical Trial Services will demonstrate quality expertise in development, monitoring, validating, and auditing processes in a regulated environment, to support the development and execution of clinical study analyses. This position requires collaboration with a multidisciplinary team, including our drug development partners. You will support the delivery of efficiently developed software product in sponsored clinical studies on time, assure the studies and documentation are in compliance with Good Clinical Practice and Good Clinical Lab Practice, software standards (IEC 62304), local regulations where applicable, and exercise effective communication skills.

Responsibilities

If you're the right candidate, you'll be exercising all the skills you have in this role, and building new ones along the way, including:

  • Coordinate with the Machine Learning, Engineering and Clinical Operations teams to analytically validate Clinical Trial algorithms.
  • Leading Internal Audits to ensure the cross-functional clinical study teams fulfill their responsibilities in accordance with the scope of work and project plan and in compliance with PathAI’s processes, regulations and relevant IEC62304/GCP/GCLP standards.
  • Implementing systems for compliance, with guidance from senior employees
  • Developing understanding of how to work in a software regulated industry
  • Monitoring trainings and documentations to ensure all employees are compliant
  • Supporting the compliance process in all phases of design and development, manufacture, and product release
  • Participation in Risk Management to ISO 14971

Requirements

  • Minimum bachelor’s degree in Software Engineering, Biomedical Engineering or related engineering field, or foreign degree equivalent plus 3 years in the software quality environment within the Medical Device Industry. A bachelor’s degree of an unrelated field would be accepted, if at least 5 years’ experience of relevant industry work has been completed.
  • 1-2 years of experience in clinical trials/drug development/clinical operations/drug manufacturing, while working with cross functional teams
  • Strong curiosity, problem-solving, communication and collaboration skills.
  • The desire and flexibility to create processes that help to increase quality and efficiency in delivering PathAI’s services to clients.
  • Knowledge of GxP, IEC 62304 and a desire to efficiently learn more along the way.
  • The ability to audit clinical trial protocols and reports, and processes
  • An understanding of compliance framework for medical interaction in relation to applicable codes of practice, regulations and SOP’s.
  • An interest to learn and continuously expand on scientific and medical knowledge.
  • Excellent problem-solving and collaboration skills

Benefits:

For the right candidate, we'll offer a competitive salary plus equity. Your compensation is rounded out by a strong benefits package:

  • Flexible work hours, with work-from-home options available 
  • Three weeks of paid leave per year, an additional two weeks of sick time, plus extended holidays and team-approved leave
  • Ten days of 100% subsidized childcare per year
  • Healthcare, vision, and dental insurance plans (HMO or PPO), with voluntary add-ons available for dependent care, life, and accident coverage
  • Commuter benefit available for public transit or parking

Most importantly, you'll be doing important work with a team of people you'll genuinely enjoy spending the day with. 

PathAI is an equal opportunity employer, dedicated to creating a workplace that is free of harassment and discrimination. We base our employment decisions on business needs, job requirements, and qualifications — that's all. We do not discriminate based on race, gender, religion, health, personal beliefs, age, family or parental status, or any other status. We don't tolerate any kind of discrimination or bias, and we are looking for teammates who feel the same way.

PathAI does not accept unsolicited submissions from third-parties. 

With the rise of employment phishing scams, especially during the current COVID-19 situation, we ask candidates to be extra vigilant. Be careful about providing any kind of personal information, such as location, age, or financial information to recruiters who may be impersonating PathAI employees. PathAI does not require payment for interviews or for applicants to purchase their own work supplies for reimbursement.