Sr Engineer Quality Design (Onsite) - Cordis

About Us:

Cordis is an independent, customer-focused global provider of interventional cardiovascular medical technologies. During our 60+ year history we’ve established a legacy of pioneering breakthrough technologies, including the first guiding catheters and coronary drug eluting stents. Cordis has built a strong global footprint that spans over 70 countries.

We’re teammates, not just employees.  Our culture empowers you to act like an owner and unleash your full potential in the process. With diverse teams on a global scale, we foster an inclusive atmosphere where everyone is embraced for who they are, their unique perspective, and what they bring to the table. 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, positive impact on the lives of millions, then Cordis is just the place for you.  Join us, and let’s improve the wellbeing of millions, together.

We are the people behind the people who keep saving lives.

The Sr Design Quality Engineer 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. Guides, Mentors and influences team members on regulatory standards and guidance’s.

• 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 include the review and approval of Design Characterization, Design Planning, Design Input, Design Output, Design Verification and Validation, Process Validation, Test Methods, Risk Management, Labeling Development, and Design Transfer.
• Responsible for acquiring and maintaining current knowledge of applicable Quality & Regulatory requirements and trends.
• Practices company safety and quality policies and procedures.

BS degree in engineering, or related discipline, and 5+ years of experience
Experience in the medical device industry.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, and CERTIFICATIONS/LICENSES:
• Must possess more than a basic understanding of engineering theoretical fundamentals and experimental techniques.
• Demonstrates ability to identify problems as well as determine and develop approaches to solutions on problems.
• Experience with mechanical drafting/drawing practices, such as ASME Y14.5.
• Demonstrates understanding of statistical techniques, design controls, process validation, risk management, and change control.

• Excellent communication skills, written oral.


ADDITIONAL POSITION REQUIREMENTS:
• While performing the duties of this job, the employee occasionally works near moving mechanical parts and may be required to work in a clean-room environment.
• Travel requirement: ~20%

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All our teammate’s points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.