Design Quality Engineer
Share
Job Location:
Monthly Salary:
Posted on:
8 hours ago
Vacancies:
1 Vacancy
Job Summary
Title: Design Quality Engineer
Location: Plano TX (onsite)
Job Description:
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
