Lead Software Engineer

Over the past decade, the company has pioneered a unique technique that measures the electrical properties of individual bacteria, enabling much faster detection of antibiotic susceptibility or resistance compared to traditional methods. After raising a pre-seed round in early 2023 and validating the technology through hospital trials, they are poised to launch its first product by the end of 2024.

Position Overview

We're seeking a Lead Software Engineer to design and implement both software and firmware, while also overseeing the user interface design for our products. This role will involve substantial hands-on coding and development with the potential to lead a software development team as the company grows.

Experience in creating software for regulated medical devices in an ISO 13485 environment is critical. The ideal candidate has a track record of delivering software to commercial markets in compliance with medical device regulations such as ISO62304. Additionally, you'll need to ensure quality standards through proper documentation, risk assessment, and code commentary as part of our design history files, subject to external validation.

Proficiency in MATLAB, C/C++, or Python is essential, with the ability to create and debug code in these languages. Experience with embedded software is a plus.

Beyond software development for our products, you will be responsible for creating software for data collection and analysis, working with the Engineering team to ensure system reliability and data processing.

As the team expands, the Lead Software Engineer will potentially oversee the recruitment and management of software engineers, including those focusing on user interfaces. This role is ideal for someone with leadership skills or ambitions who enjoys mentoring and managing team growth. The Lead Software Engineer will report to the VP of Engineering.

Key Responsibilities and Duties

• Design, implement, and document software for product pipeline, adhering to relevant medical device standards (ISO13485, ISO62304, ISO14971).
• Write efficient, logical, and well-commented code.
• Perform verification and validation of code, including module, sub-system, and system-level testing.
• Manage the software development team as needed.
• Create software for data collection and processing.
• Keep Quality Management System documentation updated (Design Inputs/Outputs).
• Collaborate with the Engineering team to ensure software-hardware integration.
• Work with the VP of Engineering, CTO, and CEO on intellectual property development and strategy.

Qualifications and Experience

• 5 years of experience creating software for life science applications.
• 5 years of experience with MATLAB, C/C++, or Python.
• Experience in medical device regulations and associated standards.
• Experience with software risk assessment and quality management systems.
• Understanding of systems and control theory.