Cordis · 3 hours ago
Senior Design Quality Engineer (Onsite)
Miami Lakes, FL
Full-time
Onsite
Senior Level
5+ years expCordis is a global leader in cardiovascular and endovascular technology, dedicated to saving lives through innovation. The Senior Design Quality Engineer will work on complex engineering projects, applying their expertise to ensure quality and compliance in product design and development.
Health CareHealth DiagnosticsMedical
Responsibilities
Works on complex problems and projects of large scope where analysis of situation or data requires a review of identifiable factors
Applies comprehensive knowledge of engineering and/or scientific principles, theories, and practices in areas of assignments, plus a working knowledge of other related disciplines
Applies comprehensive knowledge and thorough understanding of concepts, principles and technical capabilities to perform varied tasks and projects
Exercises judgement within defined procedures and practices to determine appropriate action
Develops technical solutions to a wide range of difficult problems
Solutions are innovative and consistent with organization objectives
Demonstrates full use and application of standard engineering and/or scientific principles, theories, concepts and techniques
Selects design direction or modifications of components of systems
Decides on design changes to meet revised specifications
Participates in decisions on scope of work, selection of equipment, and length of tasks
Provides and develops solutions to problems of limited scope
Completes work independently; receives general guidance on new projects
Must be able to accomplish broad and complex assignments
Work reviewed for purpose of meeting objectives
May contribute to the development of policies and procedures
May provide technical guidance to lower level personnel
May act as a mentor to less experienced colleagues
Excellent attention to detail
Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments
Plans and conducts work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria
Devises new approaches to problems encountered
Independently performs most assignments with instructions as to the general results expected
Receives technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects
Plans, schedules, conduct, and coordinate detailed phases of engineering work in part of a major project or in a total project of moderate scope
Performs work that involves conventional engineering practice but may include a variety of complex features such as conflicting design requirements, unsuitability of conventional materials, and difficult coordination requirements
Work requires broad knowledge of precedents in the specialty area and good knowledge of principles and practices of related specialties
May technically supervise or coordinate the work of engineers, draftspersons, technicians, and others who assist in specific assignments
Applies knowledge of engineering and/or scientific principles, theories, and practices in areas of assignments
Ensures appropriate engineering and scientific analyses are employed
Design Quality Engineering Group support of NPD/NBD Projects. Responsibilities of Design QE at this level may include the following: Review/Approval of Design Characterization, Design Planning, Design Input, Design Output, Design Verification and Validation, Process Validation (Installation Qualification, Operational Qualification, Performance Qualification), Test Method and Test Method Validation, Risk Management, Labeling Development, Competitive Testing, Design Transfer and Launch Planning, Design History File (DHF) verification, as well as new product supplier quality engineering responsibilities, including Supplier Quality Agreements and Purchased Material/process/Services qualifications Responsibilities of NBD include Supplier Quality Agreements, Applicable Design Control Deliverables determination, Supply Chain and Launch Planning, Finished Device Qualification and Direct Ship Strategy, as applicable
Design Quality Engineering Group responsibilities include Supplier Quality Agreements, Supplier Component Qualification and/or Finished Device Qualification during Pre-Launch phases
Data analysis support for R&D projects, where applicable
Support Complaints and Escalation or applicable CAPAs for recent project launches (pre-phase 6 closure)
Support Post-Launch design and/or significant process change projects, as applicable
Support External Audits in areas of Design Control, Product Risk Management, and Recent Project Launches, as applicable
Responsible for acquiring and maintaining current knowledge of applicable Quality & Regulatory requirements and trends
Practices company safety, quality policies and procedures, actively requires conformance
Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance
Responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company
Qualification
Required
Requires Engineering Bachelors Degree plus 5+ years of relevant experience
Preferred
Has complex level engineering experience
Experience in the medical device industry
Must possess more than a basic understanding of engineering theoretical fundamentals and experimental techniques; must possess a clear proficiency of theoretical and practical fundamentals and experimental engineering techniques
Individuals at this level should be developing skills related to conflicting design requirements, unsuitability of conventional materials and difficult coordination requirements
Experience with mechanical drafting/drawing practices, such as ASME Y14.5
Demonstrates ability to identify problems as well as determine and develop approaches to solutions on problems, using engineering and/or scientific principles as well as quality principles, including root cause analysis and corrective and preventative actions
Demonstrates understanding and application of statistical techniques, quantitative and qualitative, to facilitate design and process analysis, including improvements
Demonstrates understanding and/or application of Design Controls, Process Validation, Risk Management, and Change Control
Experience with applying knowledge of engineering and/or scientific principles, theories, and practices in areas of assignments, plus a working knowledge of other related disciplines
English communication skills, written and oral
Company
Cordis
Cordis Corporation, a Johnson & Johnson company, has pioneered less invasive treatments for vascular disease.
1001-5000 employees
H1B Sponsorship
Cordis 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
2025 (5)
2024 (3)
2023 (3)
2022 (4)
Funding
Current Stage
Late StageTotal Funding
unknown2021-03-12Acquired
Leadership Team
Scott Drake
Chief Executive Officer
Recent News
2025-11-11
TeamBest Global Companies
2025-11-07
News-Medical.Net
2025-11-01
Company data provided by crunchbase