Description
Description: Plans, directs and implements all aspects of the company's design and development of new medical device products. Oversees the investigation and evaluation of existing technologies. Guides the conceptualization of new methodologies, materials, machines, processes or products. Directs the development of new concepts from initial design to product release. Manages feasibility studies of the design to determine if capable of function as intended. Monitors documentation maintenance throughout all phases of research and development. Organizes the coordination of activities with outside suppliers and consultant to ensure timely delivery. Selects, develops and evaluates personnel to ensure the efficient operation of the function.Essential Duties and Responsibilities
- Manages the creation and development of new invasive and noninvasive medical device products
- Manages the investigation and evaluation of existing technologies.
- Manages the design and implementation of new methodologies, materials, machines, processes or products.
- Manages the development new concepts from initial design to market release.
- Maintains documentation of project plans and GLP design control throughout all phases of research and development.
- Interfaces with other departments to coordinate cross-functional project activities. Communicates project status to management.
- Mentors and supervises technical personnel.
- Experience with Endovascular Products.
- Identifies hazards and mitigates risk associated with identified hazards in Design and Process FMEA
Education, Training, Skills and Experience Requirements:
- Bachelor in engineering or related field
- Knowledge of FDA and ISO GMP design control regulation
- 8 - 12 years of working experience in medical device development or related fields and strong management and mentoring experience
To find out more about Real please visit www.realstaffing.com