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|A job at||Full time|
In the Röchling Group you’ll be shaping industry. Worldwide. Together, we are changing everyday lives – by making cars lighter, making drug packaging safer and enhancing industrial applications. With 11,000 employees in 25 countries.
In the Medical division, you will work with our customers to make pioneering contributions to disease prevention and health restoration worldwide. We offer a wide selection of custom-tailored components through to complete systems.
Responsible for process engineering activities and deliverables including process development, equipment support, documentation, process implementation, problem solving, training, and process/equipment technology transfer.
ESSENTIAL DUTIES AND RESPONSIBILITIES: include the following. Other duties may be assigned.
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 RML 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. Ability to determine manufacturability of customer product designs and be able to make suggestions for improvements on proposals from new and existing customers.
Knowledge in material selection of thermoplastic polymers for customer proposals.
Work with new and existing mold tool vendors for improvements or changes to existing mold tooling and for final design of new mold tooling for injection molded products.
Knowledge in design and operation for 3-D printing of holding fixtures, tool fixtures, and other simple to moderately complex devices.
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 OpEx efforts of the Company.
Provide other department and manufacturing support as requested by immediate supervisor.
Other duties may be assigned.
This position has no supervisory responsibilities
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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.
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write training programs. Ability to effectively present information to top management, groups of employees, and/or boards of directors.
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently required to stand, walk, and talk or hear. The employee is occasionally required to sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, depth perception, and ability to adjust focus.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently exposed to moving mechanical parts. The employee is occasionally exposed to wet and/or humid conditions, fumes or airborne particles, and vibration. The noise level in the work environment is usually loud.
To perform this job successfully, an individual should have knowledge of SolidWorks Design software; Visual manufacturing software; Microsoft Project management software; Excel Spreadsheet software and Word processing software.
CERTIFICATES, LICENSES, REGISTRATIONS
To perform the job successfully, an individual should demonstrate the following competencies:
+1 717 335 3700
Roechling Medical Lancaster
44 Denver Road
17517 Denver, PA