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 with relevant regulatory standards such as FDA’s 21 CFR Part 820 (Quality System Regulation) and IEC 62304 (Medical Device Software Lifecycle Processes).
Lead software validation and verification processes, ensuring documentation and testing meet regulatory requirements.
Collaborate with software and algorithm developers to ensure robust and compliant software design, development, and deployment.
Stay updated with changes in regulatory standards and guide the team in compliance efforts.
Support Software Development and Build Infrastructure:
Develop and maintain a robust software development lifecycle (SDLC) framework tailored to meet the needs of our diagnostic systems.
Oversee the establishment and maintenance of build and release pipelines, ensuring automated, efficient, and reliable software delivery.
Implement and manage tools and processes for continuous integration and continuous deployment (CI/CD).
Troubleshoot and resolve build and deployment issues, working closely with software developers and testers.
Continuous Improvement:
Drive continuous improvement initiatives to enhance system performance, reliability, and compliance.
Foster a culture of innovation and quality within the engineering team.
Evaluate and implement new technologies and methodologies to maintain a competitive edge.
This role is offering a salary between $225,000-265,000 and is eligible for equity offerings. Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.
The application deadline for this position is August 15, 2024.
You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
