Expedite Talent Solutions · 1 day ago
US_East | Network Design Engineer_L2
Plano, TX
Full-time
Onsite
Senior Level
5+ years expExpedite Talent Solutions is a company that is focused on providing quality engineering services in the medical device sector. The Senior Design Quality Engineer will ensure that new or modified products conform to quality standards and maintain compliance with the quality system while collaborating with cross-functional teams.
IT ManagementProfessional ServicesWarehousing
Responsibilities
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
Qualification
Required
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
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
Company
Expedite Talent Solutions
Expedite Talent Solutions is a minority- and woman-owned firm delivering agile staffing, project outsourcing, and professional services to clients across the Healthcare, Commercial, and Public Sectors.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Sandeep Singh
Associate Director / Sr. Client Partner
Company data provided by crunchbase