Design Quality Engineer

Title: Design Quality Engineer
Location: Plano TX (onsite)

Job Description:

• 6 years of Medical devices - Design Quality experience for the projects related to Design Change Clinical and New Product Development.
• Good experience in Medical devices regulations ISO13485 FDA & EU MDR regulations
• Experience in compiling Design history files & Technical file submission for 510k & CE mark
• Own Risk Management files Risk management plan Hazard Analysis DFMEA UFMEA Risk Management report
• Work with cross functional teams to execute and/or support various areas of Design Control processes such as Design Input requirements Design Outputs Design Verification and Design Validation.
• Review & approve all the design history files with cross functional teams (including software deliverables)
• Support product development equipment qualification activities test method development and validation activities.
• Strong in Medical devices technical documentation
• Excellent verbal written and interpersonal skills with ability to effectively communicate at multiple levels in the organization.
• Strong analytical/problem solving critical thinking and presentation skills.

Key Skills
Mechanical Design,SOC,System Design,GD&T,CAD,Creo,SolidWorks,Mechanical Engineering,Perl,Autocad,HVAC Design,Catia
Employment Type : Full Time
Experience: years
Vacancy: 1