Lead Software Engineer

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

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

Job Title: Lead Software Engineer

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 Lead Software Engineer is a skilled technical leader with a passion for building high quality platforms and products. The Lead Software Engineer with support from the Senior Director of Systems Engineering will lead a small teamcohort of Software Engineers to develop and implement innovative software solutions for the products and services critical to Foresight’s mission. The Lead Software Engineer will partner with cross functional stakeholders and the PMO to ensure appropriate resourcing to deliver solutions on time and on budget.

The ideal candidate will have a systems engineering experience in molecular diagnostics or the medical device industry, and an understanding of regulatory requirements, including software regulations. This role is critical in managing a team to deliver on 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 Senior Director of Systems Engineering.

What You Will Do

Leadership

• Lead a team of Software Engineers, fostering a collaborative and innovative work environment while balancing autonomy between the team and stakeholders.

• Sustain the system engineering principles defined for your team by the Senior Director of Systems Engineering in alignment with the company’s goals and regulatory requirements.

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

• Make decisions related to technical oversight with the team, including DevOps, coding, and quality assurance practices.

• Develop people through effective performance management and ongoing feedback, rewarding initiative and time management.

• Drive collaborative group reviews of architectural design with the goal of facilitating an autonomous process with fun and healthy debate.

• Promote collaboration and knowledge-sharing between engineers to mitigate wisdom-siloing and participates as an active, hands-on engineer to develop prototypes, validate proof-of-value options, develop new features, and foster continuous improvement.

System Development

• Ensure the software development process produces robust, scalable and reliable deliverables.

• Motivate quality focused software delivery, including new build and implementation of software.

• Work with product owners and the PMO to assist with product roadmaps.

• Evangelize 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 Software Engineers to execute robust validation and verification processes, ensuring documentation and testing meet stakeholder and regulatory requirements.

Direct Software Development

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

• Establish and maintain build and release pipelines, ensuring automated, efficient, and reliable software delivery.

• Delegate or coordinate and execute release management and implement contingency measures in response to release management scenarios.

• Juggle multiple tasks and fulfill ad-hoc requests based on priority.

Continuous Improvement

• In collaboration with the Senior Director of Systems Engineering, oversee the software development process, managing stakeholder satisfaction through seamless integration of software components and the flow of data in alignment with stakeholder requirements.

• Track, monitor and report on system performance, reliability, and scalability metrics to guide data driven decision making.

• Under the guidance of the Senior Director of Systems Engineering, drive continuous improvement initiatives for software process optimization, reliability, and compliance.

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

• Evaluate and implement new technologies and methodologies to optimize business efficiency.

What You Will Bring

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

• 10+ years of software engineering experience (equivalent to Principal Engineer/Software Engineer VI) in new development within the molecular diagnostics, medical device or related industry.

• 2+ years leadership experience with direct reports, management of remote teams preferred.

• 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.

• Experience with Cloud technologies, AWS and GCP.

• Strong software and data structure design, development, and architecture experience

• 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.

• Experience working in a regulated domain.

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

Compensation & Benefits

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 ***