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 s and industry standards throughout the product development process.
Applies broad knowledge of principles in a specific practice area. Independently applies extensive and diversified knowledge of principles and practices in broad areas of assignments and relates fields. Acquires general knowledge of principles and practices of related fields, and ability to function on multi-disciplinary teams.
Works on a major or several projects of moderate scope with complex features.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Able to construct plan for a complete project, system, component, or process. Prepares complete project documents. Designs and conducts experiments, and analyzes and interprets data. Formulates and solves problems.
Reviews complete project documents for conformity and quality assurance. Develops new techniques and/or improved processes, materials, or products. Assists upper level management and staff as a technical specialist or advisor.
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 Ventions 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.
Receives general direction on key objectives. Receives guidance when necessary on unconventional or complex problems, direction on modified techniques, and new approaches on assignments with conflicting criteria.
Any other duties as assigned.
May assign tasks to and direct engineers, technicians and administrative staff. May plan and coordinate detailed aspects of the Quality Assurance / Quality Engineering work. Prepares scope, budget, and schedules for required QA activities within individual projects. Assists with proposals to provide professional services or cost estimations for engineering projects or programs.
REQUIRED EDUCATION, EXPERIENCE, SKILLS AND KNOWLEDGE:
Bachelor's degree in Engineering or equivalent.
Minimum 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.
Knowledge of probability and statistics.
Depth of knowledge in one or more clinical, product or technical areas.
Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.
Possesses advanced oral and written communications skills.
o Ability to effectively interact with customers, officials, contractors, and others. Expected to attend project meetings and present specific aspects of Quality Assurance and Quality Engineering assignments.