Senior Director, Systems Engineering

*** APPLICATIONS ONLY ACCEPTED THROUGH PARTNER AGENCY WEBSITE ***

*** Apply at: Summit Human Capital ***

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 through seamless integration of software components and the flow of data in alignment with stakeholder requirements.

• Ensure system performance, reliability, and scalability metrics are tracked, monitored, and are reported on by Software Team Leads.

• Drive continuous improvement initiatives for software process optimization, reliability, and compliance.

• Foster a culture of innovation and quality within the systems engineering team.

• Evaluate and implement new technologies and methodologies to maintain a competitive edge.

What You Will Bring

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

• 10+ years of experience in system engineering within the molecular diagnostics, medical device or related industry with demonstrated experience as a Senior Architect and/or Director

• 4+ years of experience in a formal people management role, to include experience managing remote teams.

• 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, 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.

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

• Adaptable to fast-paced, dynamic work environments and shifting demands.

• Highly collaborative, promotor of high functioning teams and an effective communicator.

• Familiarity with software validation practices, quality systems, and compliance requirements to include ISO 13485, ISO 27001, IEC 62304, CMMI.

• Knowledge of bioinformatics and data analysis tools, preferred.

• Knowledge and experience medical device cybersecurity, preferred.

Desired Qualities

• Experience working in a regulated domain.

• Ability to understand and communicate needs and requirements for cloud-based execution and storage infrastructure.

This role is hiring at an annual salary of $225,000 - $265,000 and is eligible for equity and bonus 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.

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.

*** APPLICATIONS ONLY ACCEPTED THROUGH PARTNER AGENCY WEBSITE ***

*** Apply at: Summit Human Capital ***