Participates as a team member in the product development process from concept through market
introduction on a contract basis for client companies. Ensures project teams are utilizing Quality Systems and appropriate regulation standards throughout the product development process.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Investigates and evaluates material biocompatibility and appropriate methods of sterilization if applicable.
Designs and implements product and process documentation, including inspection plans.
Conducts feasibility studies of the design to determine ability to function as intended.
Maintains detailed documentation throughout all phases of research and development.
Conducts risk analysis for products under development.
Ensures outside supplier quality systems meet Vention Medical requirements and coordinates any activities with the supplier as needed.
Develops verification and validation test protocols.
Develops product submission documentation if required by the customer.
Any other duties as assigned.
REQUIRED EDUCATION, EXPERIENCE, SKILLS AND KNOWLEDGE:
Bachelor's degree in Engineering is desired.
0 - 5 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.
Familiarity with FDA QSR and ISO 13485 medical device regulations.
Familiarity with Minitab or similar data analysis package.
Knowledge of probability and statistics