Vice President of Software

Company Description

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.

As part of our team, your core responsibilities will be:

• 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 AUTO11, AAMI/UL 2900, ISO 27001, IEC 81001, etc.), including establishing cybersecurity vulnerability scanning and disclosure processes.

Qualifications

Baseline skills, experiences, and attributes:

• Expertise in developing embedded software, firmware, instrument control, and/or cloud-based diagnostic data platforms.
• Working knowledge of electronic design principles and medical device design control methods.
• Familiarity with concepts of design input, design output, traceability, security, and risk analysis.
• Strong organizational skills with the ability to prioritize tasks, self-driven and independent in leading and participating in the engineering processes.
• Knowledge of HIPAA and data privacy requirements when handling patient or test result data.
• Strong understanding of medical device software regulation and cybersecurity requirements.
• Linux developer with high code quality and adherence to open source practices and kernel development standards.
• Ability to design and implement core OS components, including kernel modifications, user-space tools, and system integrations for robustness, security, and performance.
• Ability to collaborate with hardware and IT/cybersecurity teams to ensure seamless integration and broad device compatibility.
• B.S. or M.S. in Software Engineering, Electrical Engineering, or related field with a minimum of 7 years of relevant experience.
• Experience with design and documentation of FDA-regulated medical device software products..
• Prior leadership experience in an FDA-regulated IVD or medical device environment.
• Track record of successfully delivering software for diagnostic instruments or connected lab systems.
• Experience with EMR/EHR integration with major EMR/EHR systems.
• Experience with automation, data analytics, or AI-driven diagnostic software is a plus.
• Experience implementing secure software architectures, including data encryption, access control, audit trails, and vulnerability management.

You Deeply Identify with Core Detect Values:

• Put people first. Our colleagues and our customers come first. We respect each other and celebrate our diversity. We take joy in each other’s success, and succeed or fail as a team
• Eye of the owner. We have an ownership mindset and take responsibility for all of our decisions. No problem is someone else's problem. We are frugal and use company resources as if they were our own
• No genius without grit. As innovators, we fail often but fast. We are tenacious. We push through adversity and keep getting up. We are problem solvers and always find a way
• Err on the side of doing. We are scrappy and biased toward action — everyone is an individual contributor. We allow intuition to guide us when we have imperfect information
• Move fast by working smart. We are inventors. We focus, plan, pursue, and adjust to make big things happen in a fraction of the time others can. We disagree and commit
• Always be frank. We celebrate openness and diversity of opinion. We are transparent and candid but compassionate in our feedback, and are always honest to ourselves and our customers

Additional Information

We offer great perks:

• Fully covered medical insurance plan, and dental & vision coverage - as a health-tech company, we place great worth on our teams’ well-being
• Competitive salaried compensation - we value our employees and show it
• Equity - we want every employee to be a stakeholder
• Pre-tax commuter benefits - we make your commute more reasonable
• 401k plan - we facilitate your retirement goals
• Beautiful office near the ocean-front in historic Guilford, Connecticut
• The opportunity to build a revolutionary healthcare product and impact millions of lives!

For this role, we provide visa assistance for qualified candidates.

Detect does not accept agency resumes.

Detect is an E-Verify and equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines.