Working at Freudenberg: We will wow your world!
Responsible of manufacturing schedule and its compliance.
Responsible to generate, document and close of manufacturing work orders, controls of the materials to perform each work order, complete the manufacturing documentation and manage the ERP in manufacturing module.
Develop and support the validation protocols and reports (IQ-Installation Qualification, Operational Qualification OQ-PQ-Performance Qualification). Provide objective evidence that the equipment, processes, test methods and product meet all requirements and are in compliance with the Medical Devices regulations.
Responsible for quality incident resolution into existing processes and production.
Responsible for the development of engineering studies and capacity analysis.
Responsible for maintaining and controlling the production capacity model.
Identify, initiate and leads projects to improve productivity and quality through proper investigation and data driven six sigma principals.
Responsible for the development and effectiveness of processes and people to bring the process to the sustainability stage.
Responsible for the execution of designs of experiments DOE require from the management.
Supervise the preventive maintenance execution on the production equipment.
Support to equipment assessment and inclusion in production to meet process and/or product requirement.
Focus on daily customer and process related issues to improve quality, on time delivery and process efficiencies.
Provide Engineering support for all manufacturing Kaizen events.
Attends daily production meetings to provide communication and support to daily production requirements.
Close communication with customers, QA, suppliers and product development teams on project matters, material issues, tooling and fixture design, process capability studies, and product quality issues for existing processes, products and related projects.
Support EO (Engineering Change) received in the Manufacturing Engineering department, their rejection or approval, development and implementation of any process changes and proper documentation of any such changes
The Process Engineer maintains complete and accurate records of assigned project activities per established Quality System.
Generates and maintains documentation for all internal processes, inspection criteria, Bill of Materials and other manufacturing and quality records. Conceptualizes and develops lean manufacturing processes for new and existing business opportunities, which may include new and/or modified plant equipment and process needs.
Aids with short and long-term planning for capital expenditures relating to future production requirements; leads projects involving new capital.
Maintain a vigilance to identify new potential technologies for the company.
Participate in internal audits and assists with maintaining the Quality System to ISO-13485 standards.
Maintains adherence to company policies, safety/ergonomic standards, and good housekeeping.
Minimum 3 years experience working as a process, Manufacturing or project engineer.
Bachelor of Science degree in engineering (Mechanical, Electro-Mechanical, Chemical, Materials and Industrial engineering).
Previous experience or training with project management techniques.
Technical experience in assembly lines.
Experience with transfer and validation of assembly lines.
Previous experience working in a Manufacturing environment.
Bi-lingual, at least B2 (Ingles-Spanish).
Familiarity with statistical problem solving and six sigma techniques.
Experience with validation protocols and reports, DOE, FMEA risk assessments, technical report authoring, strong statistical data analysis and recommendation reports.
Attentive to detail.
Good written and spoken communication skills.
Work with little supervision.
Make educated decisions based on facts and data.
CAD proficient in 2D dimensioning and tolerance.
Previous experience in a manufacturing environment of medical or Healthcare products and familiarity with ISO-13485 and FDA CFR 21 regulations.
Six Sigma Green Belt or Black belt Certification.
The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.
Freudenberg Medical srl.