Description
POSITION SUMMARY:Participates as a team member in the product development process from concept through market introduction on a contract basis for client companies.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
· Performs Quality Assurance tasks related to Product Development projects. Prepares portions of project documents. Edits specifications.
· 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.
· Conducts risk analysis for products under development.
· Develops verification and validation test protocols.
· Assists in determining schedule and budget requirements.
REQUIRED EDUCATION, EXPERIENCE, SKILLS AND KNOWLEDGE:
· Bachelor's degree in Engineering, or equivalent, is desired.
· 1 to 5 years of medical device product design and development experience, required.
· 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.
· Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.
· Possesses effective oral and written communication skills.