- FDA Regulations
We are seeking a high-performing individual to design and develop medical devices from concept through market introduction. The desired individual will possess a broad range of medical device design and development skills and experience, as well as depth of knowledge in several clinical, product and technical areas. The ideal candidate is a self-motivated individual who is excited by the prospect of working in a dynamic, entrepreneurial environment.
Essential Duties and Responsibilities:
Develops new concepts from initial design to market release.
Investigates and evaluates existing technology.
Designs and implements new methodologies, materials, machines, processes or products to bring concept to market, including essential product and process documentation.
Sources and identifies vendors and components for incorporation into devices.
Conducts feasibility studies of the design to determine ability to function as intended.
Maintains detailed documentation throughout all phases of research and development.
Works with mechanical designers to create new designs with proper documentation.
Coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines.
Required Education, Experience, Skills and Knowledge:
Bachelor's degree in Mechanical or Biomedical Engineering is required.
1-3 years of medical device product design and development experience.
Demonstrated ability to bring products from concept to market.
Ability to interact with client companies in a professional manner.
SolidWorks 3D CAD proficiency helpful, but not required.
Familiarity with FDA QSR and ISO 13,485 medical device regulations.
Depth of knowledge in one or more product areas; for example finite element analysis.
Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.