Design Transfer Lead Engineer

1 week ago

Schaumburg, Illinois, United States Natus Medical Full time
Job Title: Design Transfer Lead Engineer

At Natus Medical, we are seeking a highly skilled Design Transfer Lead Engineer to join our team. As a key member of our organization, you will play a critical role in the design transfer of product design to manufacturing, depot repair, and service centers.

Key Responsibilities:
  • 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 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.
Requirements:
  • Bachelor's degree in Engineering or Science.
  • 5 years of experience in medical device design and development, preferably in 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.
  • 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.
Compensation and Benefits:

We offer a comprehensive benefit package, including healthcare benefits, 401k company contributions, 7 paid holidays, 2 floaters, 4 weeks accrued PTO, and up to $5,000 tuition reimbursement annually.

Flexible work location in North America.

We are Passionate About:

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.

Our vision is to deliver innovative and trusted solutions to advance the standard of care and improve patient outcomes and quality of life.

Natus products are used in hospitals, clinics, and laboratories worldwide.

EEO Statement:

Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.

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