Design Transfer Engineer
2 mesi fa
Key Responsibilities
- Collaborate with design teams to develop strategies for manufacturing and servicing Natus medical devices.
- Define service levels, workflow, and repair locations for new and established devices.
- Act as primary technical point-of-contact between product development and internal and external manufacturing and repair sites.
- Ensure appropriate traceability between system, subsystem, process/repair verification and validation, and cross-functional deliverables.
- Manage manufacturing and service risks using PFMEA.
- Write, release, and maintain service manuals, repair instructions, and troubleshooting guides for new and established products.
- Establish Service Design Transfer within the R&D Engineering organization as an end-to-end technical expert for repair, service, and maintenance of products.
- Collect and translate design inputs from manufacturing, operations, sales, and service for new product introduction.
- Provide review and input of new designs for serviceability and manufacturability.
- Apply ISO 13485, US FDA Quality System Regulations (21 CFR 820), EU MDR, and relevant international standards to design activities.
- Coordinate activities with contributors from manufacturing, service, operations, sales, regulatory, and quality affairs, marketing, and cross-functional engineering disciplines.
- Stay up-to-date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers.
- Understand, apply, and contribute to the development of quality management systems and design controls processes.
- Identify improvement opportunities for the service engineering function and deliverables.
About Natus Medical Incorporated
Natus Medical Incorporated is recognized by healthcare providers globally as the source for solutions to screen, diagnose, and treat disorders of the brain, neural pathways, and sensory nervous system.
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