Vice President, Research and Development

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…