Offer summary

Qualifications:

Bachelor's or Master's degree in Computer Science, Biomedical Engineering, Bioinformatics, or related field., At least 8 years of experience in molecular diagnostics or medical devices industry., Over 2 years of leadership experience managing remote teams., Proficiency in Python, Java, C++, and cloud computing platforms like AWS or Google Cloud..

Key responsibilities:

Collaborate with cross-departmental teams to ensure cohesive product development.

Ensure software components comply with regulatory standards such as FDA and IEC 62304.

Lead software validation, verification, and documentation processes.

Oversee software development lifecycle, build pipelines, and system performance metrics.

Job description

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:

· Bachelors or Masters degree in Computer Science in Software Engineering, Biomedical Engineering, Bioinformatics, or a related field, with 8+ years of experience in molecular diagnosticsmedical 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 andor Google Cloud), particularly in scalable and distributed system design.

Desired:

· Previous work in startup environments, demonstrating adaptability to fastmoving and evolving priorities.

Responsibilities:

· Collaborate with interdepartmental 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 FDAs 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.

Required profile