Practitioner / consultant
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Manufacturing EngineerMust Have ISO 13485 & Medical Industry Experience in manufacturing operations as a Manufacturing Engineer (LOCAL CANDIDATES ONLY)
- Supervisory responsibilities for Assembly and Molding Operators
- 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 quality incident resolution into existing processes and production including the development of engineering studies and capacity analysis.
- 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.
- 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.
- Bachelor of Science degree in engineering (Mechanical, Electro-Mechanical, Chemical, Materials and Industrial engineering).
- 3+ years related experience working as a process, manufacturing or project engineer in an ISO 13485 and 14971 standards.
- Previous experience or training with project management techniques.
- Technical experience in plastic processing.
- Experience with Scientific Injection Molding Principles
- Previous experience working in a Manufacturing environment.
- 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.
- Excellent verbal, written, analytical, computer and interpersonal skills with the ability to demonstrate lead capabilities with team approach, and sound decision making.
- Organizational, prioritization, and presentation skills required.
- CAD proficient in 2D dimensioning and tolerance.
- Excellent interpersonal, communication, influencing, and facilitation skills.
- Ability to work effectively cross functionally.
- Detail Oriented.
- Positive, Respectful, and Professional attitude.
- Able to handle diverse activities simultaneously.
- Works well in a team-oriented, cross-functional environment.
- Ability to handle multiple tasks and operate in a fast-paced manufacturing environment.
- Good reasoning abilities and sound judgment.
- Proficiency in Microsoft Office applications, Excel in Particular.
- 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.
- Experience with injection molding, silicone, and coating.
- Working knowledge of SAP.
Freudenberg Medical, part of the Freudenberg Group, is a global partner for the design, development and manufacture of innovative medical devices and components. With 11 manufacturing operations and more than 1,500 associates worldwide, Freudenberg Medical offers a wide range of manufacturing capabilities from high precision molding and extrusion to drug coatings, finished devices, and subassemblies for catheters and minimally invasive devices.
For over 30 years, medical device and healthcare companies have trust Freudenberg Medical to manufacture their custom components and devices. We operate FDA-registered, ISO 13485 certified medical device facilities with Class 7 & 8 cleanrooms. Design and manufacturing operations are located in the United States (California, Indiana, Massachusetts, Minnesota), Germany, Ireland, Costa Rica, and China.
Freudenberg Medical’s culture is positive and team oriented. In our environment we like to have fun while helping others with our cutting edge medical devices. Our company is very driven to lead in the medical device industry to improve the quality of life of the patients we serve.
Freudenberg Medical is a local, innovative, high growth company with a collaborative, high performance work environment. We develop and manufacture minimally invasive, single use medical devices in the endoscopy, cardiovascular, neurovascular, and urology markets. The products we develop and manufacture are typically market disruptive and displace higher cost procedures.
Location: Alajuela, Costa Rica
We are currently hiring for a Manufacturing Engineer who is:
- Driven and focused on ensuring quality for all manufacturing cells in operations and New Business Activities
- Striving to utilize statistical process controls to provide daily engineering support to existing production processes
- Able to demonstrate a sense of urgency and initiative on the manufacturing floor
- Self-motivated and thrives in a fast –paced, team-driven, “lean” systems environment, where every day brings new projects and challenges.
It’s an exciting time to work at Freudenberg Medical. We know our ability to succeed depends upon the people we employ. Leading-edge technology, the highest standards, and outstanding people make Freudenberg Medical the employer of choice in this industry. We offer a competitive salary plus a full range of benefits.
Do you have any questions?
Freudenberg Medical Minimally Invasive Solutions Rachel Peterson ∙ Human Resources ∙ 2301 Centennial Blvd. ∙ 47130 Jeffersonville, IN ∙www.freudenbergmedical.com/MIS