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Design Transfer Lead Engineer
hace 2 meses
Job Summary
Natus is seeking a highly skilled Design Transfer Lead Engineer - Manufacturing and Service to join our team. As a key member of our organization, you will be responsible for leading the design transfer of product design to manufacturing, depot repair, and service centers.
Key Responsibilities:
- Collaborate with design teams to develop strategies for manufacturing and service, ensuring seamless product delivery to customers.
- Define service levels, workflow, and repair locations for new and established devices, ensuring efficient and effective product support.
- Act as the primary technical point-of-contact between product development and internal and external manufacturing and repair sites, facilitating communication and resolving technical issues.
- Manage manufacturing and service risks using PFMEA, ensuring compliance with regulatory requirements.
- Develop and maintain service manuals, repair instructions, and troubleshooting guides for new and established products, ensuring accurate and up-to-date documentation.
- 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, ensuring alignment with business objectives.
- Provide review and input of new design for serviceability and manufacturability, applying ISO 13485, US FDA Quality System Regulations (21 CFR 820), EU MDR, and relevant international standards.
- Coordinate activities with contributors from manufacturing, service, operations, sales, regulatory, and quality affairs, marketing, and cross-functional engineering disciplines, ensuring effective collaboration and communication.
- 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, ensuring compliance with regulatory requirements.
- Identify improvement opportunities for the service engineering function and deliverables, driving process improvement and innovation.
Requirements:
- Bachelor's degree in Engineering or Science.
- 5+ years of experience in medical device design and development within the medical device industry.
- 3+ years of 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.
Travel: Up to 15% domestic or international travel may be required.
