Job Description
Job Description 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. Responsibilities 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. Qualifications 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 regulated environments. Extensive experience operating within public company governance and compliance frameworks. Preferr