Manufacturing And Process Engineer

Freudenberg is a global technology group that strengthens its customers and society long-term through forward-looking innovations.
Together with our partners, customers and the world of science, we develop leading-edge technologies, and excellent products, solutions and services for 40 market segments.
The Freudenberg Group employs some 50,000 people in 60 countries worldwide and generates sales of over 10 billion euros.
At Freudenberg Medical, we make products that save and improve the lives of people every day, all around the world.
We are a global provider for medical device design and manufacturing with more than 2,000 employees.
Innovation is at the core of our company, and we are proud of our industry-leading quality, lean manufacturing, and focus on innovation in products and processing technologies.
Freudenberg Medical is an exciting place to work with lots of opportunity to learn, develop, and grow your career.
Come join us and together we can make a difference in the future of healthcare.
**Responsibilities**:

- Responsible for manufacturing schedule and its compliance including the generation, documentation 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 maintaining and controlling the production capacity model while identifying, initiating and leading projects to improve productivity and quality through proper investigation and data driven six sigma principals.
- Driving 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) required from management.
- Supervise the preventive maintenance execution on the production equipment.
- 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
- 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.
- Participate in internal audits and assists with maintaining the Quality System to ISO-13485 standards.
**Qualifications**:

- Bachelor's degree in a related technical field such as Mechanical Engineering or Plastics Engineering.
Degree in biomedical or biomechanical engineering Preferred
- 5 years minimum of related experience in a regulated manufacturing environment, preferably medical or healthcare products in an engineering role.
- 2 years minimum Project management experience in a manufacturing environment utilizing extrusion or injection molding methods
- PMP Certification in Project Management
- APICS certification
- Demonstrated experience providing leadership, managing multiple projects of medium complexity
- Working knowledge of ISO-13485 and FDA cGMP regulations
- Working knowledge of engineering terminology, extrusion and injection molding processes, tooling and validation protocols.
- Working knowledge of work centers, cost structure, and basic industrial engineering practices.
- Proficiency in basic computer skills (Word, Excel, PowerPoint, etc.)
Working knowledge of ERP/MRP software.
- Prefer experience using QAD MFG/Pro ERP software and prior experience in a product cost-estimating role for extrusion.
- Lean Systems or Six-Sigma Green Belt Certification Preferred

Your Benefits

Occupational safety: Safety as a top priority, in all aspects of your work

Diversity & Inclusion: Enter a diversity-driven world of innovation

Training / Career development: Programs to supercharge skills and expertise

Meal allowance: Allowance makes meals more affordable

Company events: Events to built teams and relationships prime for accomplishment

Additional Information

Roy Vargas
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