Staff Engineer Research and Development (Onsite)

Overview

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.

Responsibilities

Works on most assignments independently, with instructions about the general results expected. May receive technical guidance on the most unusual or complex problems, but independently determines and develops solutions. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Ensures high levels of technical excellence associated with assigned tasks, projects and work output. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Erroneous decisions or recommendations or failure to obtain results would normally result in serious program/project delay and considerable expenditure of resources.

The current position encompasses design and development responsibilities for stents, stent delivery systems, related accessory devices, and cardiovascular catheter-based technologies. The role requires relevant clinical application experience and a strong understanding of cardiovascular catheter-based clinical procedures.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Applies advanced medical device engineering knowledge and a comprehensive understanding of engineering principles to lead the design realization of new or modified medical devices in compliance with applicable global regulatory standards.
• Independently plans, scopes, and executes complex engineering projects or major project components involving unique, novel, or technically challenging problems that significantly impact organizational programs or product platforms.
• Serves as a recognized technical expert within a defined specialty area; anticipates technical challenges and develops new or improved techniques, processes, equipment, materials, and innovative test methods to address complex engineering and product development needs.
• Translates internal and external customer needs into robust design inputs and verification/validation strategies; develops, implements, and continuously improves test methods to ensure design outputs meet defined requirements and industry standards.
• Provides critical design input in complex or ambiguous situations, leveraging broad knowledge of the testing and regulatory environment to ensure technically sound and compliant solutions.
• Leads and/or contributes substantively to design reviews; ensures design verification and validation activities are scientifically rigorous, properly documented, and fully traceable to product requirements and design inputs in accordance with Design Control requirements.
• Evaluates the feasibility, technical soundness, and risk of proposed engineering solutions, particularly when data are limited or confirmation through testing is required.
• Develops and manages technical project plans, schedules, and resource estimates to ensure timely completion of assigned deliverables; proactively communicates risks, dependencies, and trade-offs with clear mitigation and contingency strategies.
• Influences and gains cross-functional alignment across R&D, Quality, Regulatory, Manufacturing, and other stakeholders to drive effective decision-making and program execution.
• Summarizes and communicates results of design work, verification/validation activities, and research studies clearly and concisely to technical and non-technical audiences.
• Participates in regulatory submission activities as a subject matter expert by providing technical justifications, reviewing regulatory documentation, and addressing technical questions during regulatory meetings and interactions.
• May technically supervise, coordinate, and review the work of engineers and technicians; provides mentorship and guidance to ensure technical rigor and adherence to quality standards.
• Ensures compliance with Quality System procedures and applicable global medical device regulations (e.g., US FDA 21 CFR Part 820, EU MDR 2017/745, ISO 13485), and supports internal and external audits with clear, data-driven evidence.
• Ensures adherence to Health, Safety, and Environmental regulations and company policies; incorporates safety and environmental considerations into equipment design, process development, and validation activities.
• Communicates significant technical, business, compliance-related risks or opportunities to management in a timely and professional manner.
• Performs other duties as assigned.

Qualifications

Required Qualifications

Requires Engineering Bachelors Degree and 8+ years of relevant experience or Master's Degree and 6+ years of experience

Preferred Qualifications

• Possesses substantial experience managing complex engineering problems and delivering technically sound solutions.
• Proven track record working within ISO 13485 and FDA-regulated environments.
• Experience in the medical device industry is required.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES AND CERTIFICATIONS/LICENSES

Advanced knowledge of engineering theory, principles, and experimental methodologies, with demonstrated ability to apply both theoretical and practical fundamentals to complex medical device development challenges.

• Demonstrated expertise in the design and development of cardiovascular catheter-based technologies, including exposure to materials selection, mechanical design, and process engineering.
• Strong working knowledge of FDA Design Controls (21 CFR 820), ISO 13485, and risk management principles (ISO 14971), including design verification/validation planning and execution.
• Proven ability to independently manage technical workstreams to meet aggressive timelines and budget constraints.
• Demonstrated technical leadership and ability to influence cross-functional stakeholders in a matrixed environment.
• Proficiency in Computer-Aided Design (CAD) tools; SolidWorks experience strongly preferred.
• Excellent written, verbal, and interpersonal communication skills, with the ability to clearly present complex technical information to diverse audiences, including regulatory bodies when required.

ADDITIONAL POSITION REQUIREMENTS

While performing the duties of this position, the employee may occasionally work near moving mechanical parts and may be exposed to electrical hazards and laboratory chemicals. The role may require work within a cleanroom environment.

Responsibilities may also involve potential exposure to human bloodborne pathogens or other potentially infectious materials, as well as exposure to radiation sources (e.g., fluoroscopy) in a catheter laboratory setting.

The noise level in the work environment is typically moderate.

GENERAL PROVISIONS

Company management reserves the right to add, delete or otherwise alter assigned duties at any time. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The minimum qualifications listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The above statements are intended to describe the general nature and level of the work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

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.