Design Control Engineer

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
Minimum of 4years of experience in Mechanical/Production Engineering

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