Sr. Design Quality Engineer

Role: Sr. Design Quality Engineer Possible 3 Month CTH Work location: Plano, Texas Background and Meet and Greet: MANDATORY Job Description: "As the Sr. Design Quality Engineer you will assure new or modified products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. What You'll Work On • Serve on product development teams promoting and assuring quality in product development projects. • Execute and support on-time completion of Design Control Deliverables for projects related to Design Change, Clinical and New Product Development. • Work with cross functional team to execute and/or support various areas of Design Control processes, such as Design Input requirements, Design Outputs, Design Verification and Design Validation. • Support the assessment/establishment of objective, measurable, discrete, and verifiable customer and product requirements. • Support product development equipment qualification activities, inspection method development and validation activities. • Review and approve design, development and verification/validation deliverables in compliance with FDA QSR requirements and ISO standards applicable to implantable medical devices. • Accountable for Applicable Standards Document & checklists, Labeling Verification planning & execution, Essential Output reports, and General Safety and Performance Requirements (GSPR). • Ensure Design History File content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps. • Lead Risk Management activities for development projects and supplier change requests, including generation and maintenance of risk assessments, risk management plan/report, hazard analysis and failure mode effects & criticality analysis (FMECA). • Maintain Risk Management Deliverables to ensure continued acceptability of products based on post market feedback. • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. • Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Required Qualifications • Bachelor's Degree in Engineering, Technical field OR an equivalent combination of education and work experience. • 5+ years of previous quality engineering experience and demonstrated use of quality tools/methodologies. • 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. • Demonstrates initiative, ownership and accountability ; plans, prioritizes and meets deadlines. • Advanced computer skills, including statistical/data analysis and report writing skills. Preferred Qualifications • Master's Degree in Engineering or Technical Field. • Previous Medical Device design and development experience. • Working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, EN 45502-1, ISO 14708, EU MDR, etc.

Created: 2026-03-04