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Design Transfer Lead Engineer
hace 2 meses
We are seeking a highly skilled Design Transfer Lead Engineer - Manufacturing and Service to join our team at Natus. This role will be responsible for leading the design transfer of product design to manufacturing, depot repair, and service centers.
Key Responsibilities- Design Transfer Leadership: Lead the design transfer process, ensuring seamless integration of product design into manufacturing and service operations.
- Manufacturing Process Development: Collaborate with design teams to develop strategies for manufacturing Natus medical devices, from electronic assemblies to high-end optical designs.
- Service Level Definition: Define service levels, workflow, and repair locations for new and established devices, ensuring optimal customer satisfaction.
- Technical Interface: Act as the primary technical point-of-contact between product development and internal and external manufacturing and repair sites, facilitating effective communication and collaboration.
- Quality Assurance: Ensure appropriate traceability between system, subsystem, process/repair verification and validation, and cross-functional deliverables, adhering to ISO 13485 and US FDA Quality System Regulations (21 CFR 820).
- Risk Management: Manage manufacturing and service risks using PFMEA, identifying and mitigating potential issues.
- Service Documentation: Write, release, and maintain service manuals, repair instructions, and troubleshooting guides for new and established products.
- Service Design Transfer: Establish Service Design Transfer within the R&D Engineering organization as an end-to-end technical expert for repair, service, and maintenance of products.
- Design Input Collection: Collect and translate design inputs from manufacturing, operations, sales, and service for new product introduction.
- Design Review: Provide review and input of new design for serviceability and manufacturability, ensuring alignment with company standards.
- Quality System Compliance: Apply ISO 13485, US FDA Quality System Regulations (21 CFR 820), EU MDR, and relevant international standards to design activities, ensuring compliance and adherence.
- Collaboration and Communication: Coordinate activities with contributors from manufacturing, service, operations, sales, regulatory, and quality affairs, marketing, and cross-functional engineering disciplines, fostering effective collaboration and communication.
- Quality Management: Understand, apply, and contribute to the development of quality management system and design controls processes, identifying improvement opportunities for the service engineering function and deliverables.
- Education: Bachelor's degree in Engineering or Science.
- Experience: 5+ years of experience in medical device design and development within the medical device industry, preferably with experience in designing products for manufacturability and serviceability.
- Skills: Ability to work within a fast-paced environment, high levels of ambiguity, multiple concurrent projects, and conflicting assignments, with initiative, attention to detail, customer focus, and commitment to ongoing process improvement.
Up to 15% domestic or international travel may be required.
