Overview Sr. Design Quality Engineer based in Plano, Texas. The role ensures that new or modified products conform to quality standards and comply with the quality system. Maintains a strong collaborative partnership with cross‑functional teams to protect patient/user safety and meet business needs. Background and meet and greet are mandatory. 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 teams to execute and/or support 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 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. #J-18808-Ljbffr