About This Role – VP of Software (Embedded)

Avails Medical is pioneering rapid diagnostics for life-threatening infections, with the goal of delivering actionable antimicrobial susceptibility results in hours, not days. Our platform is designed to empower clinicians with timely data that can help save lives and combat antimicrobial resistance.

We are seeking an experienced software leader to fill the role of VP of Software and scale our software embedded systems team. This individual must thrive in a fast paced start-up environment as they will play a critical leadership role in the design, development, and delivery of embedded software that powers our next-generation diagnostic systems. As a member of the executive team at this stage your impact is huge as you will set strategic direction, ensure engineering excellence, and collaborate across systems, and clinical teams to bring our innovative and life-saving diagnostic products to market at this most exciting time.

Key Responsibilities

Own the software strategy and technical roadmap in service of products.
Chaos startup - shifting priorities
Introducing best practices in tools (visual studio) to create and optimize
Oversee secure and scalable architecture for data handling, instrument control, algorithms, and remote diagnostics.
Collaborate with systems engineering, assay development, and hardware teams to integrate software into complete IVD solutions and external partners.
Partner with Quality and Regulatory to support compliance with FDA, ISO 13485, audits, submissions (e.g., 510(k), PMA), and post-market surveillance.
Ensure software development compliance with IEC 62304 and other relevant software regulatory standards especially related to cybersecurity of capital hospital equipment.
Drive software development practices, balancing speed with validation and compliance needs. “Autonomy”
Evaluate and implement modern DevOps, CI/CD, and automated testing approaches tailored to a regulated environment.
Grow and lead a high-performing software dev team to meet the needs of the company

Qualifications

Bachelor’s or Master’s degree in Mechanical Engineering, Electrical Engineering or Computer Science (PhD preferred).
10+ years of software leadership experience, with at least 5 in the medical device or diagnostics industry.
Deep understanding of IVD product development, especially Class II/III devices.
Proven track record leading full lifecycle development — from early prototyping to commercial deployment and post-market support.
Experience building teams and development infrastructure
Proven track record of creating, building and shipping products
Experience with regulatory software development under IEC 62304 (required).
Strong grasp of cybersecurity and modern development stacks.
Excellent leadership, communication, and cross-functional collaboration skills.
Negotiation skills are a must
Communicate with the likes of the FDA, BOD, external stake holders
Experience with global teams and/or external software development partners preferred.
STRONG critical thinking and problem solving skills - Penchant to FIX things with Go to Gemba
Tech stack exists Jira , Bitbucket Atlassian tools IR for embedded, Visual Studio

Preferred Experience

Familiarity with clinical lab workflows, LIS integration, HL7/FHIR protocols.
Exposure to AI/ML in diagnostic applications (bonus).
Previous participation in FDA submissions or inspections involving software.

Why Join Us

Work on products that directly impact patient lives and clinical outcomes.
Help define the software strategy for next-generation IVD platforms.
Join a mission-driven, collaborative culture where innovation meets rigor.

Avails Medical provides equal employment opportunity for all applicants and employees. Avails does not unlawfully discriminate on the basis of race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), gender identity, gender expression, national origin, ancestry, citizenship, age, physical or mental disability, military or veteran status, marital status, domestic partner status, sexual orientation, genetic information, or any other basis protected by applicable laws.

We are not accepting unsolicited resumes from employment agencies.

The ranges below reflect the target ranges for a new hire base salary. One is for the Bay Area (within 50 miles of HQ, Menlo Park). Actual compensation may vary outside of these ranges and is dependent on various factors including but not limited to a candidate's qualifications including relevant education and training, competencies, experience, business needs. Base pay is only one part of the total compensation package. Full time roles are eligible for equity and benefits. Base pay is subject to change and may be modified in the future.

Bay Area Pay Range

$250,000 - $300,000

Avails Medical, Inc.

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