"Alerted.org

Overview

Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

Responsibilities

The Senior Manufacturing Engineer is responsible for providing advanced technical leadership in the design, development, and optimization of manufacturing processes. This role supports scalability, quality, and cost-efficiency across production operations, ensuring full compliance with GMP and ISO 13485 standards. The Senior Engineer leads process validation and continuous improvement initiatives, working cross-functionally with Quality, R&D, and Operations to enhance reliability and operational performance.

Key Responsibilities

+ Lead complex process development and optimization projects to improve product quality and manufacturing efficiency.

+ Oversee validation activities (IQ/OQ/PQ) for new and existing equipment and processes.

+ Partner with R&D to ensure seamless design transfer and manufacturability of new products.

+ Provide technical leadership in troubleshooting and root-cause analysis of process or equipment issues.

+ Develop and maintain manufacturing documentation, including procedures, work instructions, and specifications.

+ Drive Lean and Six Sigma initiatives to reduce waste, variation, and cost.

+ Evaluate and implement new technologies, automation, and tooling to support production growth.

+ Support risk management activities, including PFMEA updates and control plan development.

+ Mentor and provide technical guidance to junior engineers and technicians.

+ Participate in CAPA investigations, audits, and inspection readiness activities.

+ Collaborate closely with Production, Quality, and Supply Chain to ensure operational alignment.

Qualifications

Required Qualifications

+ Bachelor’s degree in Mechanical, Manufacturing, Industrial, or Biomedical Engineering.

+ 5+ years of experience in manufacturing engineering within a regulated industry.

+ Strong knowledge of GMP, ISO 13485, and validation principles.

+ Proven success leading process validation, improvement, and scaling initiatives.

+ Excellent communication, project management, and technical writing skills.

Preferred:

+ Master’s degree or advanced engineering certification.

+ Lean Six Sigma Green Belt or Black Belt.

+ Experience with automation, robotics, or high-volume assembly systems.

+ Prior experience in medical device or drug-device combination manufacturing.

Preferred Qualifications

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.

Preferred Qualifications 1

Pay / Compensation

The expected pre-tax pay rate for this position is $94,600 – 127,600 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.

JOIN OUR TALENT COMMUNITY

Joining our Talent Community is a great way to receive company news and updates, as well notifications on career opportunities and events that interest you! Please tell us more about yourself so we can align you with future opportunities that match your background, skills and interests.

**Job Locations** _US-CA-Irvine_

**ID** _2025-12154_

**Category** _Manufacturing_

**Position Type** _Regular Full-Time_

CORDIS is proud to be an equal opportunity employer, values diversity in all its forms is and committed to fostering an inclusive work environment. We are committed to advancing our culture of belonging, where all teammates feel seen, heard, and appreciated and encouraged to be their authentic selves. Our team is invested in attracting, retaining and growing top talent. Our Teammates are the core of our innovation and success. Cordis is an inclusive, engaging place to work and grow a career. CORDIS is committed to offering reasonable accommodations, upon request, to job applicants with disabilities. If you need assistance or an accommodation due to a disability, please contact [email protected]