Vice President of Software

Detect’s mission is to make accurate diagnostics accessible. We build breakthrough technology at the intersection of software, hardware, chemistry, and biology to make diagnostics available at the point of need. Our ultimate goal is to lower healthcare costs, improve patient outcomes, and improve doctor experience by enabling earlier diagnosis and access to treatment.

Job Description

The VP of Software will oversee and coordinate all aspects of software and firmware engineering, from the initial feasibility stage to production release and upgrade support (software development lifecycle) for a next generation molecular in vitro diagnostic medical device and related infrastructure, i.e. Cloud infrastructure and integration with EMR/EHR systems. This position will be responsible for software design, development, and maintenance efforts including all planning, scheduling, and documentation requirements in accordance with regulatory requirements specific to medical device software and good manufacturing practices (GMPs) for design controls, e.g., software architecture, coding, code reviews, implementation, test verification and validation of the software design and function.

In addition, this position will be responsible for maintaining firmware and/or software for target PCBs, where applicable, and verifying the designs of various test production and test equipment that include software.

This role requires combining deep technical, hands‑on work with strategic leadership: designing and building core software components while defining the software roadmap, architecture, development processes, and regulatory compliance framework. It involves both contributing directly to product code and establishing the foundation for a scalable software organization. The position works cross‑functionally across hardware, product, regulatory/quality, manufacturing, and operations to deliver a robust, compliant, and scalable diagnostic software platform.

Responsibilities

• Actively leading and coordinating the software development and review process while driving ongoing process improvement across the software engineering function with minimum supervision.

• Owning/supporting all phases of the software development lifecycle (SDLC) including requirements definition, design, implementation, debug, verification, validation, transfer to manufacturing, and post‑market software maintenance and release.

• Developing system level designs and strategies and leading definition of software specifications, design implementation, and testing and refining of components and sub‑systems as they relate to software for all current and future products.

• Translating product and regulatory requirements into clear technical plans and documentation (including automated SBOM creation) to support FDA submission.

• Collaborating with product/marketing team to define product‑level requirements for future software feature expansion.

• Ensuring adherence to product design controls procedures and software development lifecycle procedures in a regulated environment.

• Developing and documenting test procedures and test reports for software unit, integration and system testing.

• Performing and documenting software risk analysis including cybersecurity threat modeling and risk assessment, and developing and documenting relevant software risk mitigations.

• Coordinating third‑party software testing (e.g., cybersecurity penetration testing).

• SW build, configuration management, change control, and development/test process improvement.

• Managing and mentoring contractors or future hires; building scalable processes for local, remote or hybrid teams.

• Maintaining compliance with medical device software regulations and standards, including specific standards/guidance from FDA, IEC, ISO, etc.

• Proactively engaging in cybersecurity risk management for medical devices, per FDA pre‑ and post‑market guidance and industry standards (CLSI AUTO
11, AAMI/UL 2900, ISO 27001, IEC 81001, etc.), including establishing cybersecurity vulnerability scanning and disclosure processes.

Qualifications

• Expertise in developing embedded software, firmware, instrument control,…