The Product / Process Engineer II will be responsible for process engineering activities and deliverables including process development, equipment support, documentation, process implementation, problem solving, training, and process/equipment technology transfer. Position reports to the Director of Engineering.
Develop new and improve existing manufacturing processes to repeatability produce high-quality medical device components. Use technical knowledge and industry expertise to develop lean and capable manufacturing processes.
Support new product development initiatives via activities including process development, manufacturing sequence analysis, PFMEA/Quality planning requirements.
Design and/or implement improvements/new fixtures and equipment to support manufacturing processes.
Conduct and analyze process tests to understand variables and interactions. Write reports (i.e. EST’s) to document tests and results. Participate in protocol development and execution of equipment IQ, process qualifications and validations per applicable internal and external procedures/standards.
Lead projects as requested pertaining to process development, fixture development, and/or equipment implementation.
Develop process and manufacturing documentation, manufacturing operation records, and associated process documentation such as preventive maintenance procedures, maintenance logs, and Good Manufacturing Practice (GMP) records.
Utilize six-sigma quality tools, when appropriate, to define, measure, analyze, improve and control processes and outcomes.
Establishes open communications and productive relationships with individuals in all levels of the organization, customers and suppliers.
Comply with FDA, ISO and internal QSR requirements
Provide status updates and ongoing communications to senior engineers, customers, management and team members through the use of project management tools.
Specify equipment, processes and products to meet customer requirements/specifications; determine critical process quality attributes.
Manage product/process development or improvement programs through Project Management.
Lead development technicians, toolmakers, and draftsmen on assigned projects, along with operational personnel as required.
Establish contacts with vendors and suppliers for services required.
Specify and order materials and components for process development and prototype manufacturing.
Use SolidWorks or similar CAD program to sketch-out and design simple to moderately complex fixtures and electro mechanical systems. .
Assist manufacturing and industrial engineers and others with standard costing and quotations. Use Visual system to establish costing, bill of materials and operational routings.
Train production and set-up personnel as required.
Assist with customer quotation proposals for new and existing customers.
Enforces and contributes to a culture of safety and GMP compliance through technical specifications, training and awareness of standards and regulations.
Solve maintenance problems and implement solutions as associated with assigned product lines.
Adhere to all Company policies, rules, procedures and housekeeping standards.
Actively participates in the TQM efforts of the Company.
Provide other department and manufacturing support as requested by immediate supervisor.
Other duties may be assigned.
EDUCATION AND/OR EXPERIENCE
Bachelor’s degree (BS) from four-year college or university in a related engineering curriculum; and five years related experience and/or training; or equivalent combination of education and experience.
Five years experience in a manufacturing environment, 3 of which in medical device manufacturing.
At least 3 years experience working in teams with 1 year in team leadership.
Working knowledge and experience with advanced principles of tolerances, pressures, electricity, temperature, strength of materials, machine elements and other physical properties.
Working knowledge of Solidworks, with ability to generate solid model and 2-D print of simple geometry.
COMPUTER SKILLS :SolidWorks Design software; Visual manufacturing software; Microsoft Project management software; Excel Spreadsheet software and Word processing software.
CERTIFICATES, LICENSES, REGISTRATIONS
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