Senior Director, System Engineering

About our Company:  Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.

About the Role: We are seeking a highly experienced and visionary Senior Director of System Engineering to lead our systems engineering team in the design, development, and implementation of our advanced cancer diagnostic systems. The ideal candidate will have a strong background in system engineering, particularly within the molecular diagnostics or medical device industry, and a deep understanding of regulatory requirements, including software regulations. This role is critical in ensuring the integration of software components and data management necessary to deliver robust and compliant diagnostic solutions.

What You Will Bring:

• Bachelor’s or Master’s degree in Software Engineering, Biomedical Engineering, or a related field.

• Minimum of 6 years of experience in system engineering within the molecular diagnostics, medical device or related industry.

• Proven track record of leading engineering teams and managing complex projects.

• Deep understanding of regulatory requirements, including CLIA, FDA, ISO 13485, 21 CFR Part 820, and IEC 62304.

• Strong knowledge of system design, integration, and validation processes.

• Excellent leadership, communication, and interpersonal skills.

• Ability to thrive in a fast-paced, dynamic environment.

• Knowledge of bioinformatics and data analysis tools, a strong plus.

• Knowledge and experience medical device cybersecurity, a strong plus

What You Will Do:

• Leadership and Strategy:

  • Lead and mentor a team of engineers, fostering a collaborative and innovative work environment.

  • Develop and execute the system engineering strategy aligned with the company’s goals and regulatory requirements.

  • Collaborate with cross-functional teams including R&D, Quality, Regulatory, and Clinical to ensure cohesive product development and operations.

• System Design and Development:

  • Oversee the design, development, and validation of diagnostic systems, ensuring integration of software components and the flow of data.

  • Ensure systems meet performance, reliability, and scalability requirements.

  • Lead the architecture and design of system interfaces, data management, and analytical tools.

• Software Regulations and Compliance:

  • Ensure all software components comply …