Exact Sciences is seeking a Principal Software Test/Quality Engineer to lead the design, implementation, and execution of software testing strategies for medical diagnostic platforms focused on cancer screening and early detection, ensuring software meets the highest standards of safety, effectiveness, and compliance with regulatory requirements.
Requirements
- 10+ years of experience in Engineering or Information Technology, with a minimum of three years of Quality Engineering technical leadership experience.
- 6+ years of experience working in an Agile/Scrum-like environment.
- 6+ years of experience using one or more tools, such as, Jenkins, GitLab, Postman, SOAPUI, JMeter, Selenium, or TestNG.
- Proven success working within a CFR 820, ISO 13485, ISO 9001 and/or cGMP structured environment.
- Technical leadership and people management skills.
- 5+ years of medical device/biotech industry experience
- Software test automation experience
Responsibilities
- Define and implement testing strategies that encompass bioinformatics pipelines, LIMS workflows, and other Clinical Laboratory Software.
- Serve as a technical mentor to the test engineering team, providing guidance in SDLC, Agile, test automation, risk-based testing, and defect prevention strategies.
- Participate in project design reviews to ensure that application designs adhere to Quality Engineering guidelines and standards.
- Apply general and QE technical expertise (e.g., system stack, test automation frameworks) and knowledge of QE standards and best practices (e.g., risk assessment methodology,) to develop quality plans that deliver solutions to the business in the most efficient and effective manner.
- Deliver software products that meet ISO13485, FDA compliant standards along with supporting documentation.
- Provide technical leadership and guidance to the internal cross-functional project team to ensure that project execution is consistent with the quality plan and SDLC.
- Works closely with internal cross-functional and external teams to influence the complete system architecture and design for systems associated with existing domains and or conceptual like-for-like technology upgrades/migrations/replacements to ensure fully testable, functioning, reliable and performing integrated systems.
Other
- Bachelor’s Degree in Engineering, Science, Biology, Chemistry, or related field as outlined in the essential duties; or High School Diploma/General Education Degree and 10 years of relevant experience as outlined in the essential duties in lieu of Bachelor’s Degree.
- Ability to work successfully in complex, matrix organizations leading through influence and direct authority across intact teams and larger organizations.
- Effective communication and presentation skills. Can communicate effectively at various degrees of altitude.
- Authorization to work in the United States without sponsorship.
- Ability and means to travel between local Exact Sciences locations.
