Role: Design Control Engineer
Location: Draper, Utah, Salt Lake City
Emp Type: Permanent Job
Interview: Phone/Skype
2-4 Yrs Total
• Design concepts for medical devices/Instruments
• Knowledge about Electro-Mechanical Devices.
• Good Understanding of MDD and MDR requirements.
• Understanding on Technical Documentation per EUMDR.
• Knowhow on 3D CAD models and specification drawings in NX/ Solid works
• Knowledge of Harmonized standards for Medical Devices (ISO 13485, ISO 14971, IEC 62366-1)
• Hands on knowledge on developing design history file, Risk Management file
· Must have experience in the Medical devices industry
· Must have experience in FDA QSR and ISO 13485
· Experience in writing Functional Requirements, Design Specifications and Risk Management Documents
• Design and develop new products for customer’s product roadmap; the role of the Product Design Engineer ranges from early concept exploration to implementation of the final product for mass production
• Develop and implement plans for research, design for manufacturing, design validation, qualification, etc. in partnership with Program Management, R&D team members, Quality, Consumer Insights
• Documentation and communication of design history, engineering change orders, etc. to multifunctional team and third party suppliers
• R&D support for manufacturing and operations as needed.
• Participation in and facilitation of face-to-face events with customers and stakeholders
• Coordinate with customers and mfg. vendors for design finalization
• Work in a team along with other designers or Quality Engineer to create the drawings necessary for prototyping and production
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Minimum of 4years of experience in Mechanical/Production Engineering