Exact Sciences is looking to solve the problem of changing how the world prevents, detects, and guides treatment for cancer by developing and managing the development of software for automated diagnostic medical devices.
Requirements
- 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.
- 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
- Expert computer skills to include engineering software, electronic records systems, internet navigation and email usage.
Responsibilities
- 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.
Other
- 5+ years of supervisory experience with demonstrated ability to hire, lead, develop and train direct reports effectively.
- Authorization to work in the United States without sponsorship.
- 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.
- Expert in Microsoft Office programs, such as: Word, Excel, PowerPoint, Outlook, Teams, OneNote, SharePoint, and Project or equivalent.
