Vice President Research And Development

Must have Extensive Surgical Robotics experience

The Vice President/CTO will be responsible for leading a team of engineers who will develop high quality innovative products while meeting project timelines. This role will develop products and supporting documentation in compliance with FDA / ISO 13485 regulations and company procedures and reports to the CEO

Duties/Responsibilities

• Directs, designs, and implements a comprehensive product management strategy.
• Functions as the central resource with design, manufacturing, quality and test, and marketing as the product(s) move to completion and distribution.
• Directs those involved in the design, modification, and evaluation of all phases of a specific product or group of products from product definition through production and release (i.e., Product Lifecycle Management).
• Ensures that products meet specifications, standards and quality goals as outlined by US FDA standards.
• Formulates and executes long-term plans for cost/profit control.
• Selects, develops, mentors and evaluates personnel to ensure the efficient operation of the R&D project execution.
• Operates as a key technical contributor on cross-functional development teams.
• Provides guidance and training to a team of engineers on the creation of Design Controls and Design History Files for complex medical devices.
• Provides a breadth of technical knowledge to overcome complex multivariate problems.
• Develop a deep understanding of our medical devices and their specific needs.
• Physically oversee and manage existing R&D employees in Korea.

Required Skills/Abilities

• Sound knowledge of complex electromechanical medical devices.
• Sound knowledge of design control processes and requirements for medical device.
• Sound knowledge of the manufacturing environment and quality controls with a passion for continuous process improvement.
• Advanced management and leadership knowledge to lead cross-department project teams or manage across multiple functions to achieve desired results.
• Knowledge of FDA Good Manufacturing Practices, ISO 13485-2016 and 14971, 510k and EU Regulations / Standards within Medical Devices.
• Must understand the complexity of the business and be able to navigate and communicate effectively within a matrix structure at the site and global level.

• Has experience in working in high performance organizations and has a proven track record of developing high performing teams and fostering a positive culture with a high degree of integrity and professionalism.
• Ability to concisely communicate status, needs, forecasts, risks and timelines effectively to executive team and all levels of the organization (one-on-one and large groups) in South Korea and the United Stated.
• Strategic thinker with the ability to analyze, understand and effectively communicate deep technical material to all levels of the organization.
• Must be a detail and goal orientated, self-motivated individual with the ability to multi-task
• Ability to travel internationally.
• Working knowledge of Software Development (working knowledge) URS, SRS, etc.
• Great interpersonal skills and works well across the matrix with cross-functional teams in Quality, Regulatory, Operations and Marketing, among others.
• Clear communication on achievements and challenges to focus on the most critical activities while understanding the big picture and the technical aspects with high attention to execution and quality.
• Excellent verbal and communication in both Korean and English.

Preferred Skills/Abilities

• Experience in robotics preferred.
• Experience in leading and managing multiple complex projects.
• Extensive experience in the creation of Design History Files and design controls, experience in DHF remediation a plus.

Education and Experience

• Bachelor’s degree in science or related field is required. An advanced degree with an emphasis in engineering or related field is preferred.
• Minimum 10 years of R&D experience with minimum 8 years of senior management experience.
• Experience in leading and managing multiple complex projects.