Job Description

Principal Bioinformatics/Software Test Engineer at Exact Sciences summary:

The Principal Bioinformatics/Software Test Engineer at Exact Sciences leads the design and execution of software testing strategies for cancer diagnostic platforms, ensuring compliance with regulatory standards such as ISO 13485 and FDA requirements. This role involves mentorship, strategic quality plan development, and collaboration with cross-functional teams to deliver reliable, high-quality software impacting patient outcomes. The position requires technical leadership in Agile environments, expertise in test automation, and experience in regulated medical device or biotech industries.

Help us change lives

At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others.

Position Overview

At Exact Sciences, we are cancer fighters. We are united by our mission to change lives by providing earlier, smarter answers. Through advances in cancer detection and treatment guidance, we will help eradicate the disease and the suffering it causes.

We are seeking a highly experienced 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. This role is a key contributor to ensuring that our software meets the highest standards of safety, effectiveness, and compliance with regulatory requirements.

 

You will collaborate closely with software developers, bioinformatics scientists, systems engineers, and quality/regulatory teams to build robust test frameworks, identify risks, and ensure reliable product performance that directly impacts patient outcomes.

Essential Duties

Include, but are not limited to, the following:

• 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.
• Set clear objectives for team members of full-time and on-shore/off-shore contractors utilizing best practice models and metrics to continually assess progress and improve.
• Directly influence and co-define Quality Engineering strategic direction, roadmap, technology, and processes. Partner with business and technology teams to prioritize roadmaps, requirements, balancing business need with capacity and technology constraints.
• 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.
• Create adaptive and Innovative Quality Engineering architecture, tools, and techniques, which includes optimization of hybrid off-shore/on-shore resourcing and application of best of breed, risk-based testing methods, levels, and types.
• Consistent demonstration of exceptional leadership qualities, including but not limited to the ability to attract and retain the best team, foster a culture of high performance, lead with integrity, humility, accountability, and courage, and set a clear vision to energize teams towards the future.
• Effectively manage, support, and guide your team, including, but not limited to delegating tasks and responsibilities, assess employee performance and provide helpful feedback and training opportunities.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company’s Quality Management System policies and procedures.
• Maintain regular and reliable attendance.
• Ability and means to travel between local Exact Sciences locations.
• Ability to act with an inclusion mindset and model these behaviors for the organization.

Minimum Qualifications

• 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.
• 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. Ability to drive continuous improvement in organizational performance and efficiency.
• 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. 
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• 5+ years of medical device/biotech industry experience
• Software test automation experience
• Experience with test management tools
• Experience with Next Generation Sequencing

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Salary Range:

$171,350.00 - $290,950.00

 

The annual base salary shown is for this position located in US - CA - San Diego on a full-time basis. In addition, this position is bonus eligible.

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits .

Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here .

Not ready to apply? Join our Talent Community to stay updated on the latest news and opportunities at Exact Sciences.

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability, protected veteran status, and any other status protected by applicable local, state, or federal law.

To view the Right to Work, E-Verify Employer, and Pay Transparency notices and Federal, Federal Contractor, and State employment law posters, visit our compliance hub . The documents summarize important details of the law and provide key points that you have a right to know.

Keywords:

software testing, bioinformatics, quality engineering, test automation, medical devices, cancer diagnostics, regulatory compliance, Agile, ISO 13485, FDA compliance

Job Tags

Full time, For contractors, Local area,

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