QA - Design Engineer II (Engineering)
Responsible for supporting the Quality Manager with all quality related support for the life cycle development of Class I, II and III medical devices, including new product development and maintenance of released products. This position requires leadership skills, the willingness and ability to mentor Quality Assurance Technicians.
Essential Duties and Responsibilities:
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Education and Experience:
Bachelor's degree required preferably in an Engineering or Engineering Technology discipline.
At least three years' experience in a Quality Control or Quality Assurance position required, preferably in a Medical Device Company.
Experience with Imaging & Resection devices preferred.
Experience in leading Risk Assessment, Failure Mode and Effects Analysis, and Fault Tree Analysis activities during Design & Development and Post Market Surveillance activities preferred.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Knowledge of ISO 14971, GD&T, design control requirements, testing and inspection equipment and techniques. Manufacturing process knowledge. Technical knowledge in development methodologies, design, and project implementation.
Machine, Tools, and/or Equipment Skills:
Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), SAP or similar inventory software.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.