Capgemini Engineering · 1 day ago
Sr. Design Quality Engineer
Dallas, TX
Full-time
Onsite
Senior Level
$62K/yr - $150K/yr
5+ years expCapgemini Engineering is a world leader in engineering services, bringing together a global team to help innovative companies unleash their potential. They are seeking an experienced Sr. Design Quality Engineer to ensure new or modified products conform to quality standards, maintain compliance with quality systems, and collaborate with cross-functional teams to protect patient safety and meet business needs.
ConsultingMechanical EngineeringInformation TechnologyInformation ServicesInnovation Management
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
Benefits
Paid time off based on employee grade (A-F), defined by policy: Vacation: 12-25 days, depending on grade, Company paid holidays, Personal Days, Sick Leave
Medical, dental, and vision coverage (or provincial healthcare coordination in Canada)
Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)
Life and disability insurance
Employee assistance programs
Other benefits as provided by local policy and eligibility
Company
Capgemini Engineering
Capgemini Engineering is a global innovation and engineering consulting firm.
Founded in 1982Paris, Ile-de-France, FRA
10001+ employees
H1B Sponsorship
Capgemini Engineering has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (1)
2021 (12)
2020 (24)
Funding
Current Stage
Public CompanyTotal Funding
$4M2019-06-24Acquired
2006-09-19Post Ipo Equity· $4M
1990-01-05IPO
Leadership Team
Joao Neiva
Automotive Mobility Experience Offer Leader
Pascal Brier
Group EVP Strategy, Technology & Inovation
Recent News
2025-11-23
Mexico Business
2025-11-19
Company data provided by crunchbase