Design Transfer Lead Engineer

1 settimana fa


Roma, Lazio, Italia Natus Medical Incorporated A tempo pieno

Job Summary

Natus Medical Incorporated is seeking a highly skilled Design Transfer Lead Engineer - Manufacturing and Service to join our team. As a key member of our product development team, you will be responsible for leading the design transfer of product design to manufacturing, depot repair, and service centers.

Key Responsibilities

  1. Design Transfer and Manufacturing
  • Develop strategies to manufacture Natus medical devices, including electronic assemblies and high-end optical designs.
  • 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.
Service Design and Deployment
  • 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.
Quality and Regulatory Compliance
  • 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.
Travel and Collaboration
  • Travel up to 15% domestic or international for business purposes.
  • Collaborate with cross-functional teams to deliver product to customers.

Requirements

  • Bachelor's degree in Engineering or Science.
  • 5+ years of experience in medical device design and development, preferably in a medical device company.
  • 3+ years of experience in designing products for manufacturability and serviceability, including creating assembly instructions and service manuals.
  • Ability to work in a fast-paced environment with high levels of ambiguity, multiple concurrent projects, and conflicting assignments.
  • Initiative, attention to detail, customer focus, and commitment to ongoing process improvement.
  • Knowledge of medical device technology, applicable quality and safety standards, and regulations.
  • Manufacturing, service, and repair deployment.
  • Information technology: PCs, servers, software, and databases.
  • Experience with project management a plus.
  • Ability to communicate effectively in written and spoken English.

What We Offer

  • Competitive salaries.
  • Pension scheme.
  • Flexible work arrangements.
  • Friendly and talented colleagues.
  • Online learning opportunities.
  • Chance to work with world-class products.


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