General Description: Under minimal direction, responsible for the development and maintenance of respiratory or other medical products; organizes and manages multiple projects and ensures projects are completed in a timely manner; creates design ideas for new products as well as creative solutions to existing products when problems arise or modifications are requested; and performs other related duties as required.Responsibilities (In order of importance): Organization Plan and control: Conducts research or development projects associated with the design and design modifications of medical devices, components, models, or mechanisms.Prepares or coordinates formal documentation of the product Designs, Risk Analysis, Product Specifications, Market Specifications, etc.according to established Product Development Procedures, and initiates formal reviews to get approved per said procedures.Develops, maintains and publishes product Development Plans for assigned projects with critical milestones and timelines.Coordinates the running protocols for the validations of new or modified devices or components, including validations of the design, manufacturing process, assembly, packaging, and sterilization where applicable.Investigates and resolves technical problems involving product performance., Coordinates the product design and development process with appropriate support departments such as engineering, regulatory, sterilization, quality, documentation, tooling and manufacturing.Serves as the project leader for assigned projects and responsible to follow up on all aspects of projects, including reviews with support groups and outside resources where applicable.Prepares or follows up on preparation of design drawings, specifications, estimates of costs, mainframe updates, etc.Discusses and consults with Product Managers to facilitate sales or customer feedback on product requirements and specification where design or manufacturing problems are involved.Works with manufacturing in the justification and the selection of the manufacturing process, and assigns projects and establishes priorities to ensure deadlines and goals are achieved.Develops assembly methods and procedures; creates engineering drawings and specifications.Coordinates changes in process, tooling and equipment identified to positively impact the manufacturing process, while staying within GMP guidelines.Coordinates the reporting on project status for all responsible projects and directs reports in formal periodic project review meetings, which include cost reduction, progress, and capital spending and expense status.Enhances growth and development through participation in education programs, current literature, training meetings and workshops.Participates actively in continuous quality improvement activities through compliance with safety standards.Demonstrates professional responsibilities by cooperating with other personnel to achieve department objectives and maintain good employee relations, interdepartmental objectives, and departmental goals and objectives.Communications: Ensure effective communication of changes related to their responsibilities.Timely notification of situations that require immediate action.Constant communication with the rest of the members of the department and other areas.Academic/ Educational Requirements: Bachelor or Master of Science degree in engineering or closely related field.Intermediate to advance conversational English (written, read and spoken).Experience/ Skills Required: Technical skills SolidWorks or CADD (Design and Drawing) (Desirable).Project management.Knowledge on ISO 13845 and related Medical regulations standards.Knowledge in ISO and ASTM testing methods foe medical devices and general plastic components.Proficient on Microsoft Office, Adobe and Minitab.1+ years of experience in an engineering or quality position within the Medical device industry.(Desirable).
