Associate Director, Systems Software

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Position Overview

The Associate Director, Systems Software leads senior staff who manage the development and testing of instruments, software, and equipment used in clinical laboratories to perform diagnostic tests. The Associate Director works with cross functional teams to ensure that user, customer, and business needs are correctly captured and translated into design specifications, implemented, verified and validated under Quality System design control. This role applies strong technical, project and personnel management skills to ensure project success and to develop engineering staff to assume roles with increasing responsibility.

Essential Duties

Include, but are not limited to, the following:

• Direct the architecture, development, and validation of complex systems software used in automated diagnostic medical devices, ensuring robust design control, reliability, manufacturability, and cybersecurity compliance.
• Lead and mentor a multidisciplinary team of senior engineers and/or subordinate managers, setting clear performance expectations and guiding career development to build future leadership capacity.
• Develop and implement departmental plans that align software engineering objectives with business, regulatory, and product strategies; adjust priorities and allocate resources based on organizational needs.
• Anticipate and address complex technical and operational challenges, applying systems thinking and advanced critical problem-solving to drive effective and scalable solutions across teams.
• Establish engineering best practices in design, development, verification, and validation processes, ensuring compliance with CFR 21 Part 820, ISO 13485, IVDR, and other relevant regulations.
• Has direct experience architecting, designing, developing, and testing software.
• Collaborate across functions (e.g., R&D, Quality, Product, Regulatory) to ensure requirements are captured, translated into technical specifications, and executed with high quality and traceability.
• Coach teams on systems thinking, planning, and execution, ensuring that project and departmental goals are effectively coordinated and milestones are tracked for measurable progress.
• Ensure risk management is integrated into the development lifecycle, proactively identifying and mitigating software and system risks across development phases and across teams.
• Champion a culture of inclusion, quality, and continuous improvement, modeling leadership behaviors aligned with the company's mission and core values.
• 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.

Minimum Qualifications

• Ph.D. in Software Engineering or field as outlined in the essential duties; or Master's Degree in Software Engineering or field as outlined in the essential duties and 4 years of additional experience in lieu of a PhD; or Bachelor's Degree in Software Engineering or field as outlined in the essential duties and 6 years of additional experience in lieu of a PhD.
• 5+ years of relevant experience working in medical device, IVD, biotech, pharmaceutical, healthcare, molecular biology, biochemistry, or related field.
• 5+ years of supervisory experience with demonstrated ability to hire, lead, develop and train direct reports effectively.
• Demonstrated ability to successfully develop and manage the development of software used in automated diagnostic medical devices.
• Demonstrated proficiency with CFR 21 part 820, ISO 13485, and IVDR compliance.
• Expert computer skills to include engineering software, electronic records systems, internet navigation and email usage.
• Expert in Microsoft Office programs, such as: Word, Excel, PowerPoint, Outlook, Teams, OneNote, SharePoint, and Project or equivalent.
• 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

• Master's degree or Ph.D. in engineering, computer science, or related field.
• 10+ years of relevant industry experience including 5+ years managing high performance software or embedded software teams.
• 3+ years managing or leading high performance software or embedded software teams.
• Experience with the product lifecycle for an FDA regulated medical devices.
• Mastery of multiple programming languages and advanced software architecture expertise.
• Basic knowledge of relational databases and a database query language such as SQL.
• Knowledge of cybersecurity principles as applied to the medical device industry.
• Skilled at scheduling projects including resource planning and workload distribution

Salary Range:

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.

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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.

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