Manufacturing Engineer

Experience in Design for Manufacturing (DFM), Lean Manufacturing, Design of Experiments (DoE), technology/process transfer experience, product/process failure mode and effects analysis (FMEA), and problem-solving methodologies

Understanding of medical device design controls/quality systema and product development processes

Highly self-motivated individual with a collaborative determination to achieve set goals

Experienced with creation and implementation of new manufacturing processes and documentation for disposable medical devices including but not limited to adhesive bonding and laser bonding

Experienced in supply chain, supplier process development/optimization

Experience in a regulated environment; Preferably medical device

Knowledge of FDA regulations and interpretation of FDA regulations, guidelines, and policy statements

Excellent verbal/written communication skills

Ability to organize, records, and implement procedures