Principal Manufacturing Engineer, Selution (Irvine, CA)
Apply NowCompany: Cardinal Health
Location: Irvine, CA 92620
Description:
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.
Our flagship product, SELUTION, combines pharmaceuticals with a traditional balloon catheter, revolutionizing treatments for coronary and peripheral artery diseases. With four Investigational Device Exemptions (IDEs) approved and actively enrolling patients (Coronary ISR, Coronary De Novo, Peripheral SFA, and Peripheral BTK), Cordis is leading the way in delivering transformative medical solutions.
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.
The Principal Manufacturing Engineer will be responsible for the development, evaluation, and optimization of manufacturing processes and methods, utilizing knowledge of product design, materials, fabrication processes, tooling, equipment, and quality control standards.
Responsibilities
Develop highly capable manufacturing processes for existing products in manufacturing. Ensure robust transition from product development thru full rate production ensuring process stabilization.
Develop, and qualify new tooling and equipment.
Draft design of a workspace, including materials and equipment, using computer drafting programs.
Update FMEA's and QCP's for NPI.
Verification/Validation of processes, machines, and equipment to meet requirements of Company procedures. IQ/OQ/PQ protocols.
Create and sustain routers and standards.
Troubleshoot product/process related issues, perform root cause analysis to develop and implement corrective and preventative action plans.
Interface with all internal organizations with supporting new product development, introductions, technologies, and supporting systems.
Work with vendors to identify operational equipment and automation solutions.
Develop and manage project plans for major operational improvement activities.
Qualifications
Pay / Compensation
The expected pre-tax pay rate for this position is $122,650 - $154,000
Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
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.
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.
Our flagship product, SELUTION, combines pharmaceuticals with a traditional balloon catheter, revolutionizing treatments for coronary and peripheral artery diseases. With four Investigational Device Exemptions (IDEs) approved and actively enrolling patients (Coronary ISR, Coronary De Novo, Peripheral SFA, and Peripheral BTK), Cordis is leading the way in delivering transformative medical solutions.
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.
The Principal Manufacturing Engineer will be responsible for the development, evaluation, and optimization of manufacturing processes and methods, utilizing knowledge of product design, materials, fabrication processes, tooling, equipment, and quality control standards.
Responsibilities
Develop highly capable manufacturing processes for existing products in manufacturing. Ensure robust transition from product development thru full rate production ensuring process stabilization.
Develop, and qualify new tooling and equipment.
Draft design of a workspace, including materials and equipment, using computer drafting programs.
Update FMEA's and QCP's for NPI.
Verification/Validation of processes, machines, and equipment to meet requirements of Company procedures. IQ/OQ/PQ protocols.
Create and sustain routers and standards.
Troubleshoot product/process related issues, perform root cause analysis to develop and implement corrective and preventative action plans.
Interface with all internal organizations with supporting new product development, introductions, technologies, and supporting systems.
Work with vendors to identify operational equipment and automation solutions.
Develop and manage project plans for major operational improvement activities.
Qualifications
- Bachelor's degree in engineering or related science discipline [required]
- 8+ years of experience in a manufacturing environment [required]
- Class III, IIb Implantable Medical Device experience
- 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
- Must be able to work under minimal supervision
- Own project level goals involving multiple engineers
- Break down ambiguous tasks into clear milestones to ensure progress can be measured
- Knowledge of Validation/Verification process, Gage R&R, and a clear understanding of FDA's QSR and GMP
Pay / Compensation
The expected pre-tax pay rate for this position is $122,650 - $154,000
Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
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.