Principal Design Quality Engineer

Overview:

Why join Cordis? For more than 60 years, we have been building interventional vascular technology that offers higher quality and less invasive experiences for people around the world. With a global reach and vast network of resources, we empower you to do your best work and unleash your full potential. Do you want to grow your career surrounded by a supportive team of subject matter experts? Then join us and let's improve the wellbeing of millions, together. 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 teammates 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.

The Principal Design Quality Engineer works on complex problems and projects of large scope where analysis of situation or data requires an in-depth evaluation of various factors. Determines direction and adequacy of designs and test results and recommends changes. Exercises judgement within broadly defined practices and policies in selecting methods and techniques to obtain desired results. Provides solutions to a wide range of difficult problems. Solutions provided by the fully qualified incumbent are imaginative, thorough and practicable. Erroneous decisions or recommendations or failure to achieve results might cause serious delays in project/program schedules and considerable expenditure and resources. Requires a wide application of principles, theories and concepts in the functional engineering field plus a working knowledge of other related disciplines. Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects. Participates in the development of policies and procedures to achieve specific goals. Recommends new practices, processes, metrics, or models. Works on or may lead complex projects of large scope Projects may have significant and long-term impact. Provides solutions which may set precedent Independently determines method for completion of new projects. Receives guidance on overall project objectives. Acts as a mentor to less experienced colleagues. Excellent attention to detail.

Please note, at this time Cordis is not sponsoring applicants for any type of work visas. It is a condition of employment that an applicant is authorized to work in the U.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 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.

• BS degree in engineering, or related discipline, and 5-9 years experience required.
• MS in engineering, or relevant discipline, may be an asset
• Has significant, complex level engineering experience
• Experience in the medical device industry required

REQUIRED KNOWLEDGE, SKILLS, ABILITIES

• Must possess a clear mastery of theoretical and practical fundamentals and experimental engineering techniques
• Must have ability to manage several projects
• Must possess clearly recognizable outstanding technical qualifications and leadership
• Strong understanding of mechanical drafting/drawing practices, such as ASME Y14.5.
• Must demonstrate 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.
• Must demonstrate understanding and application of statistical techniques, quantitative and qualitative, to facilitate design and process analysis, including improvements.
• Must demonstrate understanding and/or application of Design Controls, Process Validation, Risk Management, and Change Control.
• Must possess 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.

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 ones identity. All our teammates 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.

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