Design Transfer Lead Engineer
hace 4 semanas
In this critical role, you will play a leading part in the design transfer of product design to manufacturing, depot repair, and service centers. Your expertise will be instrumental in architecting manufacturing processes and implementing strategies for the delivery of product service and repair to our customers. You will act as a key interface between product development, manufacturing engineers, technical service, repair centers, and sales to deliver product to our customers.
Key Responsibilities:- Collaborate with the design team to develop a strategy for manufacturing Natus medical devices, spanning from electronic assemblies to high-end optical designs.
- Define service levels, workflow, and repair locations for new and established devices.
- Act as the 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 design 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 system and design controls processes.
- Identify improvement opportunities for the service engineering function and deliverables.
Travel: up to 15% domestic or international travel.
Education and Experience: Bachelor's degree in Engineering or Science. 5+ years experience in medical device design and development within medical devices preferable. 3+ years experience in designing products for manufacturability and serviceability, including creating assembly instructions and service manuals. Ability to work within a fast-paced environment, high levels of ambiguity, multiple concurrent projects, and conflicting assignments. Initiative, attention to detail, customer focus, and commitment to ongoing process improvement.
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