Vice President, Research and Development

The Vice President of Research & Development (VP, R&D) is a senior executive responsible for defining and executing the company's innovation strategy to deliver safe, effective, and commercially successful medical devices. This leader will oversee the full product lifecycle-from concept and feasibility through development, verification/validation, regulatory submission, and post‑market support-while ensuring alignment with business objectives, regulatory requirements, and patient needs.

The Vice President leads a Research and Development organization of 75 team members and partners closely with Regulatory, Quality, Clinical, Operations, and Commercial leaders to accelerate time‑to‑market, build scalable development capabilities, and foster a culture of scientific excellence, accountability, and innovation.

Essential Functions & Accountabilities:

R&D & Technology Strategy:

* Define and execute a long‑term R&D strategy that integrates medical hardware, embedded software, cloud platforms, data analytics, and AI/ML capabilities.

* Build and manage a balanced portfolio spanning incremental innovation, platform development, and disruptive technologies.

* Align R&D priorities with corporate strategy, multi‑year financial plans, and public company growth commitments.

Software & AI‑Enabled Product Development:

* Lead development of software‑as‑a‑medical‑device (SaMD), software in a medical device (SiMD), digital health platforms, and AI/ML algorithms.

* Establish development practices compliant with IEC 62304, FDA SaMD guidance, Good Machine Learning Practices (GMLP), and cybersecurity standards.

* Ensure AI systems are clinically validated, explainable, secure, and ethically deployed, with strong post‑market monitoring and model lifecycle management.

Regulatory, Quality & Compliance Leadership:

* Ensure R&D outputs meet global regulatory requirements including FDA, EU MDR/IVDR, and international software and AI regulations.

* Partner with Regulatory and Quality to support major submissions, inspections, and responses to regulatory inquiries.

* Embed quality‑by‑design, software risk management, data integrity, and cybersecurity throughout development.

Clinical & Evidence Strategy:

* Collaborate with Clinical Affairs to generate clinical evidence supporting software, algorithms, and connected device claims.

* Support real‑world evidence (RWE) and data‑driven performance monitoring post‑launch.

* Integrate human factors, usability engineering, and patient experience into product design.

Public Company Governance & Executive Accountability:

* Provide clear, data‑driven updates on R&D performance, risks, and milestones to executive leadership and the Board of Directors.

* Support investor confidence through predictable execution, portfolio clarity, and credible long‑range innovation plans.

* Partner with Finance and Legal to support earnings forecasts, disclosures, and risk management related to R&D initiatives.

Leadership & Organization Development:

* Build and lead world‑class, multidisciplinary teams spanning hardware, software, data science, systems engineering, and clinical.

* Attract, retain, and develop top technical and leadership talent in competitive global markets.

* Foster a culture of accountability, innovation, and continuous improvement.

Operational Excellence & Scalability:

* Implement modern development tooling, agile practices (where appropriate), and portfolio governance to improve speed and predictability.

* Optimize R&D spending, vendor strategy, and global development footprint.

* Ensure design for manufacturability, scalability, and lifecycle cost efficiency.

Travel:

* Able to travel 25% + (60+ days) nationally and internationally.

Knowledge, Skills and Abilities:

Required:

* PhD, MS, or equivalent advanced degree in Engineering, Computer Science, Biomedical Engineering, or related field.

* 15+ years of progressive R&D leadership experience in medical devices, digital health, or regulated healthcare technology.

* Proven track record delivering software‑ and AI‑enabled medical products from concept to global commercialization.

* Deep knowledge of medical device regulations, software standards, and AI governance in…