Product Process Engineer Level I

This person is responsible for engineering activities associated with assigned product lines including process and product design development, documentation, implementation, problem solving, maintanance, training and technology transfer, hands-on assistance, and supervision.

This person is responsible for implementing small to intermediate tasks and sub tasks, acquires and integrates knowledge of all kinds as the liaison between the customer or other stakeholders; influence and directs others through team leadership both formal and informal.   They will establish open communication and productive relationships with individuals in all levels of the organization, customers and suppliers.  They will be responsible for compliance to FDA, ISO and internal QSR and be responsible for various QSR documentation.  They will also be responsible for product/process feasibility, development, validation and integration of manufactuirng processes, equipment and products.  They will provide feedback, planning, and communications to senior engineers, customers, management and team members through the use of project management tools.  This person will specify equipment, processes, and products in order to achieve customer satisfaction and determine critical quality attributes, prioritize, organize, and get results.  They are responsible for designing by self or others, simple to moderately complex fixtures and electro mechanical systems.  They assist manufacturing and industrial engineer and others with standard costing and quotations.  They maintain communication with manufacturing on established products concerning changes, revisions, problems and take necessary action.  They develop processa and manufacturing documentation, prepare manufacturing operation records, prepare appropriate documentation such as operator manuals, maintenance logs, and Good Manufacturing Practice (GMP) records.  They manage complete product/process development or improvement programs through Project Management.  They also supervise development technicians, toolmakers, and draftsmen on assigned projects, along with operational personnel as required.  They establish contact with vendors and suppliers for services required and specify and order materials and components for prototype manufacturing.

Bacholor's degree from four-year college or university in a related engineering curriculum and eight years related experience and/or training is required.  Five years experience in a manufacturing environment, three of which are in medical device manufacturing are also required.  At least five years experience working in teams with three years in team leadership and working knowledge and experience with advanced principles of tolerances, pressures, elecricity, temperature, strength of materials, machine elements and other physical properties are also required.  Working knowledge of Solidworks with ability to generate solid model and 2-D print of simple geometry is required.

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