Senior Director, Systems Engineering

Summary

Join Foresight Diagnostics, a venture-backed molecular diagnostics company, as their Senior Director of Systems Engineering. Lead the Software Systems Engineering team, driving implementation of architecture and processes supporting critical products and services. Collaborate with various departments to develop, implement, deploy, and maintain scalable solutions. Ensure compliance with regulatory standards (ISO 13485, FDA 21 CFR Part 820, IEC 62304) throughout the software development lifecycle. Oversee software development processes, integration of components, and data management for robust diagnostic solutions. This full-time position reports to the CTO and offers a competitive salary, equity, and bonus opportunities.

Requirements

• 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

Responsibilities

• 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
• 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
• 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
• 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

Preferred Qualifications

• Knowledge of bioinformatics and data analysis tools, preferred
• Knowledge and experience medical device cybersecurity, preferred
• Experience working in a regulated domain
• Ability to understand and communicate needs and requirements for cloud-based execution and storage infrastructure

Benefits

• Paid vacation
• Sick time
• Parental leave (if applicable)
• Medical
• Dental
• Vision
• Life
• Disability coverage
• Flexible spending accounts
• A 401k with company match