Supports medical device manufacturing processes, including LSR and thermoplastic injection molding and cable-to-connector soldering. Designs and improves manufacturing processes, tooling, fixtures, and documentation; evaluates equipment; validates processes; troubleshoots production issues; and applies Gage R&R, SPC, Cp, Cpk, 5S, and value stream mapping. Collaborates with vendors and cross-functional teams while supporting FDA, QMS, EMS, and other regulatory requirements.
Company Description
- This position will support manufacturing processes for medical implant and medical external cable assemblies with a primary focus on injection molding and soldering of cables to connectors.
- This position will design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality.
- List the significant/essential duties, tasks or responsibilities which employees in this position are required to perform.
- Support Liquid Silicone Rubber (LSR) injection molding processes on a BOY machine and thermoplastic injection molding processes on Illinois Precision Corporation (IPC) machine Support soldering processes of cables to connectors
- Design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality
- Evaluation of production equipment Production support and process validation Interface with vendors for incoming components Troubleshoot manufacturing process and equipment Utilize tools like Gage R&R, Cp, Cpk, and SPC to improve processes
- Understand manufacturing concepts like Value Stream Mapping, 5S and Visual Workplace to improve quality, labor efficiency, and throughput.
- Protocol and report writing Generate and modify manufacturing process documentation Work with cross-functional teams as required Develop and implement process improvements
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S.
- Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Performs other related duties and responsibilities, on occasion, as assigned.
Equipment:
- List the type of equipment the incumbent will utilize in this position.
- May, on occasion, work with a variety of production equipment, small hand tools, test equipment, and precision measuring instruments.
- Also uses standard office equipment such as telephone, fax/copier, and a personal computer with standard office software.
- Describe the work environment characteristics representative of those encountered by an employee performing the essential functions of this job.
- Work environment varies from well-lighted office/cubicle, low to moderate noise level, to a variety of conditions caused by travel requirements such as customer offices, research labs, hospitals, hotels, use of automobiles, commercial travel, weather, etc.
- Physical Demands: Describe the physical demands representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Activities require a significant amount of sitting in front of a computer monitor, some standing and walking.
- Significant use of hands and arms, plus finger dexterity to reach, point, write, type, operate a computer and other office equipment.
- Performs tasks that regularly require good correctable vision and hand/eye coordination.
- Activities also require significant use of voice and hearing for discussions with other employees.
If you are looking for a change and if you are interested in this job, you can contact me for more details.
Direct Number- 734-984-4499
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