Process Engineer II (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:

The Engineer II will support development, evaluation, and improvements of manufacturing processes and methods. The engineer will support validation efforts to increase site capabilities and capacity, including but not limited to, insourcing and expansion activities for the site. Will be working in a fast passed environment to ensure all deliverables and projects tasks are met on time. They will also support any LSM/VIP projects, as well as identifies areas of opportunity with Process Excellence tools in order to reduce the cost of manufacturing the products and continue with the culture of continuous improvements for Cordis.

• Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
• Verification/Validation of processes, machines, and equipment to meet requirements of Company procedures. Support and execute IQ/OQ protocols.
• Support and/or lead factory acceptance testing (FAT) for new equipment.
• Documentation and reporting of engineering evaluations performed.
• Perform characterization and baseline development for new technologies and/or products.
• Studies the processes to implement improvements.
• Develop and qualify new test methods.
• Perform characterization evaluations for WIP components.
• Identifies potential business related issues or opportunities.
• Receives general guidance and instruction on new projects.
• Works with Environmental, Health & Safety (EHS) practices and ensures that all manufacturing equipment meets the required standard. Modifies and enhances equipment as needed.
• Support in development of highly capable manufacturing processes for existing products in manufacturing.
• Ensure robust transition from product development through full rate production ensuring process stabilization.
• Actively participate in complaint investigations.
• Interface with all internal organizations with supporting new product development, introductions, technologies, and supporting systems.
• Support with production non-conformances as required.
• Update procedures with process improvements as required.
• Leads software validations for new and/or optimized equipment(s).
• Assist with site audits, as needed.
• Performs other assigned tasks, as needed.

Qualifications:

Required Qualifications

Requires Engineering Bachelors Degree and 3+ years of relevant experience.

Preferred Qualifications:

• Ability to work independently and as a member of a team
• Knowledge of MS Suite – MSWord, Excel, PowerPoint, Project, Visio, JDE, etc.
• Knowledge of DOEs, materials processing, manufacturing processes, extrusion, polymers, lab testing equipment, lab tests, etc. would be assets.
• Previous experience working in a clean room environment
• Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the organization
• Strong organization and follow-up skills, as well as attention to detail
• Ability to work effectively in a team environment
• Knowledge of Validation/Verification process and Gage R&R
• Understanding of statistical analysis
• Strong analytical and problem solving
• Six Sigma Certification preferred

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.