Senior Design Quality Engineer (Onsite)

Cordis•Miami Lakes, FL

4h•Onsite

About The Position

When you join the team at Cordis, you become part of an inspiring mission to save lives, impacting millions of people and broadening access to life-saving cardiovascular and endovascular technology. As a global leader for over 60 years, we are dedicated to being the heart of innovation to transform cardiovascular care. At Cordis, we're teammates, not just employees. We embrace an empowered and one-team culture where teammates are inspired to unleash their full potential. With diverse teams on a global scale, we believe the richness of our experiences and backgrounds enhances the careers of our teammates, the service to our customers, and ultimately, the lives of our patients. If you love a challenge and are ready to have a direct, transformative and positive impact on the lives of millions, then Cordis is just the place for you. We are the people behind the people who keep saving lives.

Requirements

Requires Engineering Bachelors Degree plus 5+ years of relevant experience.

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.