Senior Director, Systems Engineering

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Job Title: Senior Director, Systems Engineering

Location: Remote, Hybrid, or Onsite in Boulder, CO

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

The Senior Director of Systems Engineering will lead the Software Systems Engineering team and will be responsible for driving implementation of architecture and processes that support product and services critical to Foresight’s mission. The Senior Director of Systems Engineering will partner with the PMO, Product Software, and Laboratory Informatics leaders to develop, implement, deploy, and maintain scalable and sustainable solutions, while managing Systems Engineering leaders and professionals.

The ideal candidate will have a strong background of systems engineering in molecular diagnostics and/or the medical device industry, and a deep understanding of regulatory requirements, including software regulations. The ideal candidate will possess in-depth knowledge of medical device regulations (ISO 13485, FDA 21 CFR Part 820, and IEC 62304), with hands-on experience ensuring compliance across the software development lifecycle, including risk management, design traceability, SaMD documentation, and FDA submission-readiness elements like SBOM, cybersecurity posture, and software validation. This role is critical in managing software development processes, ensuring the integration of software components, and data management necessary to deliver robust and compliant diagnostic solutions.

This is a full-time position working standard business hours, but may require the flexibility to work diverse schedules, including evenings, weekends, and holidays. This position reports to the CTO.

What You Will Do

Leadership and Strategy

• Lead Software Engineering teams, fostering a collaborative and innovative work environment.

• In collaboration with the CTO, develop and execute to system engineering principles aligned with the company’s goals and regulatory requirements.

• Collaborate with inter-departmental owners and leaders including R&D, Quality, Regulatory, and Clinical to ensure cohesive product development and operations.

• Establish organization wide software standards and best practices, guiding the design of systems and the relevance of development analysis.

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).

• Drive (Lead) Software Engineers and Architects to execute robust validation and verification processes, ensuring documentation and testing meet stakeholder and regulatory requirements.

• Stay updated with changes in regulatory standards and guide the team in compliance efforts.

Direct Software Development

• Ensure the Software Development Life Cycle (SDLC) frameworks selected to meet the needs of our diagnostic systems are being adhered to.

• Oversee the establishment and maintenance of build and release pipelines, ensuring automated, efficient, and reliable software delivery.

• Enforce contingency measures are enabled in response to release management scenarios.

Continuous Improvement

• Oversee the software development process, managing stakeholder satisfaction th