Summit Human Capital is seeking a highly motivated Lead Software Engineer to support a Venture Backed Cancer Detection company. This position is an exciting opportunity to support a highly funded startup with some of the best engineers in the industry. The ideal candidate will meet the following criteria.

Requirements:

· Bachelor's or Master's degree in Computer Science in Software Engineering, Biomedical Engineering, Bioinformatics, or a related field, with 8+ years of experience in molecular diagnostics/medical devices, or related industry.

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

· Extensive knowledge of software validation, quality systems, and compliance standards (CLIA, FDA, IS013485, IEC 62304, and 21 CFR Part 820)

· Expertise in Python, with additional proficiency in Java and C++.

· Strong background in cloud computing (AWS and/or Google Cloud), particularly in scalable and distributed system design.

Desired:

· Previous work in start-up environments, demonstrating adaptability to fast-moving and evolving priorities.

Responsibilities:

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

· 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.

· 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.

· 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.