R&D Manager

Intuitive•Durham, NC

About The Position

The R&D Manager, Advanced Tissue Models will be responsible for leading a multidisciplinary team of engineers and scientists, tasked with designing, developing, and transferring Intuitive’s Advanced Tissue Models into production. This position will provide technical leadership, oversight and cross-functional collaboration to ensure the delivery of innovative, high-quality solutions. The manager will align team efforts with organizational priorities, foster a performance-driven and collaborative environment, and ensure compliance with regulatory and quality standards.

Requirements

Demonstrated leadership experience in R&D or engineering management, preferably within medical device, healthcare simulation, or related fields.
Proven track record in engineering project management, technical leadership, and team development.
Advanced knowledge of product design, development lifecycle, material science, and/or biomechanical engineering.
Experience overseeing projects involving development of synthetic materials, prototyping, and transfer to production.
Demonstrated expertise in design for manufacturing to optimize product designs that are efficient in manufacturing, supply chain and labor time.
Strong understanding of experimental design and statistical tools and methods (eg. design of experiments, analysis of variance, and capability studies).
Experience interacting with surgeons, physicians, and cross-functional technical teams.
Ability to communicate technical concepts clearly to stakeholders at all levels and across disciplines.
Effective communication skills include oral, written, and interpersonal.
Experience with quality management systems, change and design control, and good documentation practices.
Proven success in recognizing critical issues with the ability to react quickly under pressure and driving issues to closure by providing coordinated direction and problem-solving creativity.
Bachelor’s degree in Engineering (Mechanical, Biomedical, Material Science, or related discipline required).
8+ years of progressive engineering experience with at least 3 years in a technical leadership or management role.

Nice To Haves

Master’s degree or PhD in a relevant technical or engineering discipline.
Experience in medical device product development/realization, including materials development, product design, and transitioning from R&D to manufacturing.
Knowledge and lab experience with human cadaver and porcine anatomy.
Experience managing vendor relationships and cross-functional project teams.
Familiarity with lean manufacturing, six sigma, and continuous improvement methodologies.
Experience creating training materials, work instructions, and technical documentation.
Familiarity with regulatory environments, including FDA and ISO, and material compliance regulations, including RoHs and REACH.

Responsibilities

Lead, mentor, and develop a high-performing, multidisciplinary team of scientists and engineers.
Lead innovation and develop efficient, cost-effective design solutions by leveraging cutting-edge technologies and materials research.
Collaborate with advanced product development teams and product managers to stay abreast of new Intuitive product offerings, training needs and user requirements.
Collaborate with product managers to develop long-range Advanced Tissue Models product pipeline.
Set team priorities and goals aligned with organizational strategy.
Oversee project execution for the design, development, testing, and effective transfer to production of Advanced Tissue Models.
Ensure adherence to new product development process and phase gate deliverables and approvals.
Maintain individual contributor responsibilities by leading technical projects, leading research studies, and leveraging subject matter expertise to advance project objectives.
Lead significant design iterations on released products to meet revised user needs, performance, reliability, quality, and cost targets.
Lead CAPAs as applicable.
Ensure rigorous research, prototyping, and validation processes across models and synthetic materials.
Hire, train and develop high performing staff.
Support the professional growth of team members through coaching, performance management, and personal development goal setting.
Evaluate individual and team performance and provide ongoing feedback.
Foster an environment that encourages creativity, open communication, and crisp, effective execution.
Maintain productive and safe lab and engineering environments.
Identify, communicate, and help the team proactively manage technical and project risks.
Oversee resource allocation, project timelines, budgeting, and vendor management.
Oversee adherence to regulatory requirements, quality systems, and good documentation practices.
Proponent of voice of the customer internally through close engagement with product management and end customers, such as surgeons and customer trainers.
Represent the department in cross-functional meetings and present technical information clearly to internal and external stakeholders.