Sr. Director of Product Development

The Senior Director of Product Development is a strategic and technically skilled leader who is responsible for the innovation and delivery of our hardware and soft good medical devices. This role will be responsible for defining the strategic technology roadmap for physical products, managing the entire product lifecycle from research and concept through to commercialization. This role will lead a multidisciplinary team of designers, engineers, technical staff, and program managers, ensure the successful execution of R&D initiatives while collaborating with the Tactile Medical Digital Solutions team to advance our product offerings. The ideal candidate will bring deep technical expertise, strong leadership, and a passion for advancing healthcare technology

• Champion a culture of advanced research and innovation, identifying new technologies, materials, and processes to drive the next generation of physical products
• Define the strategic roadmap for all physical products, aligning with company goals and market needs. Balance long-term exploratory research with near-term product deliverables
• Build, mentor, and lead a high-performing, multi-disciplinary team of hardware and soft goods engineers, project managers, and designers
• Oversee the full product lifecycle, from initial concept and prototyping to manufacturing and product launch, ensuring the highest standards of quality, performance, and timelines
• Provide strategic oversight for all physical product projects, ensuring they are executed efficiently, on time, and within budget
• Serve as a key liaison between the physical product team and other departments, including Digital Solutions, Marketing, Regulatory, Quality, and Operations
• Drive the creation of new IP and other foundational technologies to secure our market position and fuel future product innovation
• Ensure compliance with medical device regulations (FDA, ISO 13485, IEC 60601)
• Collaborate cross-functionally with software, regulatory, quality, and manufacturing teams
• Develop and manage budgets, timelines, and resource allocation for R&D program
• Maintain high standards of documentation, risk management, and design controls

Education & Experience:

• Bachelor's degree in electrical, mechanical, or biomedical engineering. Master's degree preferred.
• Minimum of 15 years of physical product development and commercialization experience in a regulated environment.
• Minimum of 10 years in a leading engineering teams and program managers.
• Demonstrated ability in overseeing a Product Development Process.
• Proven experience in medical device development and regulatory compliance.
• Strong leadership, communication, and project management skills.
• FDA or ISO 13485 training certifications

Preferred:

• Certified Quality Engineer (CQE)
• Project Management Professional (PMP)
• Lean Six Sigma Green/Black Belt

Knowledge & Skills:

• Ability to define and execute long-term technology and product roadmaps aligned with organizational goals.
• Deep knowledge of hardware and soft goods engineering, materials science, and medical device development standards (FDA, ISO 13485, IEC 60601).
• Demonstrated ability in overseeing a Product Development Process including formal phase gates and structured project report outs
• Skilled in fostering a culture of advanced research, identifying emerging technologies, and driving IP creation.
• Expertise in managing end-to-end product development-from concept and prototyping to commercialization.
• Strong ability to partner with digital solutions, regulatory, quality, manufacturing, and marketing teams.
• Proven experience in leading, mentoring, and scaling multidisciplinary teams.
• Competence in resource allocation, timeline management, and ensuring projects meet quality and cost objectives.
• Ensures adherence to medical device regulations and maintains robust design controls and documentation