Design Quality Engineer

Title:
Design Quality Engineer

Location:
Plano, TX (only onsite, no remote)

Long Term Contract Role

JD (Updated):

• 6+ years of Medical devices – Design / Development Quality experience on the projects related to Design Change, Clinical and New Product Development. New Product Development experience is a must.
• Experience working on implantable Class III medical devices or safety critical embedded systems is a must.
• Experience with software development life cycle (IEC 62304), verification/validation practices, and risk-based quality engineering.
• Good experience in Medical devices regulations – ISO
  13485, FDA & EU MDR regulations
• Experience in compiling Design history files & Technical file submission for 510k & CE mark
• Own Risk Management files and ensure adherence to ISO 14971 – Risk management plan, Hazard Analysis, SFMEA, DFMEA, UFMEA, Risk Management report, etc.
• 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, inspection / 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.
• Working knowledge of cybersecurity requirements, software configuration management, and requirements management tools (e.g., Polarion, Doors, Jira) would be preferred.